Brand Name | IV3000 1 HAND 10X12CM CTN 50 |
Type of Device | TAPE AND BANDAGE, ADHESIVE |
Manufacturer (Section D) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
hull east riding of yorkshire HU3 2 BN |
UK HU3 2BN |
|
Manufacturer (Section G) |
SMITH & NEPHEW MEDICAL LTD. |
101 hessle road |
|
hull east riding of yorkshire HU3 2 BN |
UK
HU3 2BN
|
|
Manufacturer Contact |
holly
topping
|
7000 west william cannon drive |
austin, TX 78735
|
5123913905
|
|
MDR Report Key | 13423277 |
MDR Text Key | 285162173 |
Report Number | 8043484-2022-00046 |
Device Sequence Number | 1 |
Product Code |
KGX
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional,User Facility |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup,Followup,Followup |
Report Date |
04/01/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Catalogue Number | 4008 |
Device Lot Number | 2051 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
01/14/2022 |
Initial Date FDA Received | 02/02/2022 |
Supplement Dates Manufacturer Received | 02/02/2022 02/02/2022 04/01/2022
|
Supplement Dates FDA Received | 02/03/2022 02/24/2022 04/01/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Age | 44 YR |