MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2012-08-29 for 3M SCOTCHCAST WET OR DRY CAST PADDING WDP2 manufactured by 3m Health Care.
[2928608]
Customer reported to 3m that a male pt presented at the clinic with green discharge under the cast. Upon removal, the 3m scotchcast wet or dry cast padding was wet and there was blistering. In the process, the clinic staff cut off a patch of skin from his hand and a little came off from his forearm. Reportedly, the pt returned, and the skin on his hand and forearm had peeled. The pt was prescribed silvadene and referred to a plastic surgeon. There was no info provided regarding any further treatment. No other adverse pt effects were reported. If additional info is received, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: D, B5
[10016227]
Pt info was not available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2012-00030 |
| MDR Report Key | 2726510 |
| Report Source | 04,05,06 |
| Date Received | 2012-08-29 |
| Date of Report | 2012-07-26 |
| Date of Event | 2012-07-25 |
| Date Mfgr Received | 2012-07-26 |
| Device Manufacturer Date | 2001-12-01 |
| Date Added to Maude | 2012-09-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANDREA GRABANSKI |
| Manufacturer Street | 3M CENTER BLDG 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517331047 |
| Manufacturer G1 | ROGERS COPR |
| Manufacturer Street | ONE TECHNOLOGY DR PO BOX 217 |
| Manufacturer City | ROGERS CT 06263021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06263 0217 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SCOTCHCAST WET OR DRY CAST PADDING |
| Generic Name | 890.3025 PROSTHETIC AND ORTHOTIC ACCESS |
| Product Code | ITG |
| Date Received | 2012-08-29 |
| Model Number | NA |
| Catalog Number | WDP2 |
| Lot Number | 2016 12 04 |
| ID Number | NA |
| Device Expiration Date | 2016-12-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-29 |