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 | 13236917 |
MDR Text Key | 283683079 |
Report Number | 8043484-2022-00026 |
Device Sequence Number | 1 |
Product Code |
KGX
|
UDI-Device Identifier | 05000223417406 |
UDI-Public | 05000223417406 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Consumer,User Facility,Company Representative |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
03/27/2022 |
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 Expiration Date | 07/28/2023 |
Device Model Number | 66024008 |
Device Catalogue Number | 4008 |
Device Lot Number | 2031 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 01/11/2022 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
12/27/2021 |
Initial Date FDA Received | 01/12/2022 |
Supplement Dates Manufacturer Received | 03/25/2022
|
Supplement Dates FDA Received | 03/27/2022
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 07/29/2020 |
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 |