Brand Name | UNKNOWN ALLEVYN LIFE |
Type of Device | DRESSING,WOUND,OCCLUSIVE |
Manufacturer (Section D) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
hull HU3 2 BN |
UK HU3 2BN |
|
Manufacturer (Section G) |
SMITH&NEPHEW MEDICAL(SUZHOU) LIMITED |
no.12 wuxiang road. |
comprehensive free zone,west z |
suzhou 21502 1 |
CH
215021
|
|
Manufacturer Contact |
markus
poettker
|
schachenallee 29 |
aarau 5001
|
SZ
5001
|
|
MDR Report Key | 6506868 |
MDR Text Key | 73500874 |
Report Number | 8043484-2017-00119 |
Device Sequence Number | 1 |
Product Code |
NAD
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
user facility |
Reporter Occupation |
Health Professional
|
Type of Report
| Initial,Followup |
Report Date |
06/28/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 04/20/2017 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Lot Number | 201613 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 03/23/2017 |
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|