MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-16 for 3M? STERI-DRAPE? 2 INCISE DRAPE N/A 2045 manufactured by 3m Health Care.
[102714214]
3m made unsuccessful attempts to obtain additional information for this report. Although medical intervention was not specified, an mdr report was submitted based on the photo of the skin injury provided with the initial report. End of report.
Patient Sequence No: 1, Text Type: N, H10
[102714215]
A hospital employee reported a patient experienced a skin injury when a 2045 3m? Steri-drape? 2 incise drape was removed following a laparotomy procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00031 |
| MDR Report Key | 7346369 |
| Date Received | 2018-03-16 |
| Date of Report | 2018-03-16 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2018-03-06 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-03-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDA JOHNSEN |
| Manufacturer Street | 2510 CONWAY AVE 3M CENTER BUILDING 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374376 |
| Manufacturer G1 | 3M COMPANY BROOKINGS |
| Manufacturer Street | 601 22ND AVE SOUTH |
| Manufacturer City | BROOKINGS SD 57006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3M? STERI-DRAPE? 2 INCISE DRAPE |
| Generic Name | INCISE DRAPE |
| Product Code | PUI |
| Date Received | 2018-03-16 |
| Model Number | N/A |
| Catalog Number | 2045 |
| Lot Number | 2022-07 AS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-03-16 |