Brand Name | 3M MICROPORE SURGICAL TAPE |
Type of Device | TAPE AND BANDAGE, ADHESIVE |
Manufacturer (Section D) |
3M HEALTH CARE |
2510 conway ave |
st. paul MN 55144 |
|
Manufacturer (Section G) |
3M DEUTSCHLAND GMBH WERK KAMEN |
edisonstrasse 6 |
59174 kamen |
kamen, deu, |
GM
|
|
Manufacturer Contact |
nadia
battah
|
3m center, building 275-5w-06 |
2510 conway ave |
st. paul, MN 55144-1000
|
6514612670
|
|
MDR Report Key | 17411043 |
MDR Text Key | 319929280 |
Report Number | 2110898-2023-00069 |
Device Sequence Number | 1 |
Product Code |
KGX
|
UDI-Device Identifier | 04064035099688 |
UDI-Public | 04064035099688 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | EXEMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Health Professional |
Reporter Occupation |
Nurse
|
Type of Report
| Initial,Followup |
Report Date |
08/02/2023 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 1530-1 |
Device Lot Number | 105126291 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 07/18/2023 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
07/05/2023
|
Initial Date FDA Received | 07/27/2023 |
Supplement Dates Manufacturer Received | 07/05/2023
|
Supplement Dates FDA Received | 08/02/2023
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/23/2022 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Required Intervention;
|
Patient Sex | Female |
|
|