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Medical Device Complaint USA/CAN
*
1.
Contact Information (Clinic)
(Required.)
Contact Person
Company Name
Email Address
Phone Number
*
2.
Affected Device
(Required.)
Talee (cranial remoulding orthosis)
Talee Post-Op (cranial post-op synostosis orthosis)
Talee Protect (protective orthosis)
8sole (foot orthotics)
Piro (paediatric ankle foot orthosis)
Raptor Mask (protective face mask)
Augo (prosthetic socket)
*
3.
Device CN
(Required.)
*
4.
Accident Date
(Required.)
Date / Time
Date
January
February
March
April
May
June
July
August
September
October
November
December
1900
1901
1902
1903
1904
1905
1906
1907
1908
1909
1910
1911
1912
1913
1914
1915
1916
Su
Sunday
Mo
Monday
Tu
Tuesday
We
Wednesday
Th
Thursday
Fr
Friday
Sa
Saturday
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
*
5.
Accident type
(Required.)
Device Quality
(e.g. product break, crack, surface quality issue, colour quality issue, excessive wear)
Device Performance
(bad fit, wrong trim-line, excessive pressure points, insufficient treatment outcomes)
Device Specification
(e.g. wrong colour, wrong ankle joint type, wrong product type)
Product Safety
(e.g. serious injury, serious product safety issue, reportable incidents)
General
(e.g. late shipment, no tracking number, no response from support, packaging / labelling issue, other)
*
6.
Description of accident
(Required.)
7.
Documentation (photo / document)
In case of product quality issue, always include photo documentation.
Choose File
No file chosen
You can send additional photos to support@inventmedical.com
*
8.
Customer Request
(Required.)
*
9.
Did accident result in affecting patient's health?
(Required.)
No
Yes - minor health problem, without long-term effect
Yes - long-term health damage
Yes - incident resulted in severe health damage or death
10.
If patient's health was affected, please provide more information here.
*
11.
Was this accident reported by you to Healthcare Authority?
(Required.)
Yes
No
Current Progress,
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