MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-01 for SCOTCHCAST PLUS manufactured by 3m Company, 3m Health Care.
[134738487]
The provider was asked for the supplies to use on a patient and when they opened the package the cast was somehow activated and they had to replace with a different one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8296705 |
| MDR Report Key | 8296705 |
| Date Received | 2019-02-01 |
| Date of Report | 2019-01-17 |
| Date of Event | 2019-01-09 |
| Report Date | 2019-01-17 |
| Date Reported to FDA | 2019-01-17 |
| Date Reported to Mfgr | 2019-02-01 |
| Date Added to Maude | 2019-02-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCOTCHCAST PLUS |
| Generic Name | BANDAGE, CAST |
| Product Code | ITG |
| Date Received | 2019-02-01 |
| Lot Number | 1809KL/1808EM |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M COMPANY, 3M HEALTH CARE |
| Manufacturer Address | 3M CENTER, 2510 CONWAY AVE. BLDG. 275-5W-06 SAINT PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-01 |