MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-01-08 for 1019 manufactured by 3m Health Care.
[174127667]
No sample was returned for evaluation. Without supplemental and complete information, including pictures, conclusions about causation cannot be determined. A review of historical complaint data showed no adverse trending. 3m will continue to monitor. End of report.
Patient Sequence No: 1, Text Type: N, H10
[174127668]
Hospital alleged a (b)(6) male, african american had third degree burn from the 3m? Steri-drape? U-drape 1015. Location of burn was not provided. Size of injury was 20 cm by 25 cm with additional areas varying of severity. Patient received a skin graft on the third degree burn. Symptoms included: erythema, edema, blisters, skin tears, burning, pain, and partial and full thickness skin damage. Patient does not have a history of skin sensitivities, dermatological pathology's, or allergies. No skin preps were used prior to application of the drape. Hospital reported the patient is "recovering as expected from surgery".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2020-00001 |
| MDR Report Key | 9563777 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-11-21 |
| Date Mfgr Received | 2019-12-09 |
| Device Manufacturer Date | 2019-09-26 |
| Date Added to Maude | 2020-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DIANNE GIBBS |
| Manufacturer Street | 3M CENTER, BUILDING 275-5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M EDUMEX |
| Manufacturer Street | EDUMEX SA DE CV |
| Manufacturer City | JUAREZ, 32605 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32605 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | 3M? STERI-DRAPE? PLASTIC SPECIALTY DRAPE |
| Product Code | PUI |
| Date Received | 2020-01-08 |
| Catalog Number | 1019 |
| Lot Number | 2024-09 ED |
| 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; 2. Required No Informationntervention | 2020-01-08 |