Brand Name | REMOVE WIPES BOX OF 50 01 |
Type of Device | SOLVENT, ADHESIVE TAPE |
Manufacturer (Section D) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
hull, HU3 2 8N |
UK HU3 28N |
|
Manufacturer (Section G) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
|
hull, HU3 2 8N |
UK
HU3 28N
|
|
Manufacturer Contact |
sarah
freestone
|
101 hessle road |
hull, HU3 2-BN
|
UK
HU3 2BN
|
|
MDR Report Key | 7982340 |
MDR Text Key | 124265114 |
Report Number | 8043484-2018-00337 |
Device Sequence Number | 1 |
Product Code |
KOX
|
Combination Product (y/n) | N |
PMA/PMN Number | NA |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Type of Report
| Initial,Followup |
Report Date |
12/26/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 10/18/2018 |
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Lay User/Patient
|
Device Catalogue Number | 403100 |
Date Manufacturer Received | 09/20/2018 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
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 |
Patient Outcome(s) |
Other;
Required Intervention;
|
|
|