MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-12-27 for 3M SCOTCHCAST WET AND DRY CAST PADDING WDP2 manufactured by 3m Health Care.
[3107852]
Customer reported a (b)(6) female patient presented with blisters on her foot about 3 inches below the knee with no reaction where the stockinet was at the end of the short leg cast, and was treated with antihistamine, prescription steroid cream and antibiotics. It was reported the patient did not get the cast wet and had contact dermatitis.
Patient Sequence No: 1, Text Type: D, B5
[10366882]
No lot number was provided with product. Without lot number it is not possible to determine the product expiration date or manufacture date. Product was available for evaluation applicable to the reportable event but it had not been returned to the manufacturer. The product was not returned to 3m for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2012-00071 |
| MDR Report Key | 2896036 |
| Report Source | 06 |
| Date Received | 2012-12-27 |
| Date of Report | 2012-11-16 |
| Date of Event | 2012-11-14 |
| Date Mfgr Received | 2012-11-16 |
| Date Added to Maude | 2013-01-07 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA JOHNSON |
| Manufacturer Street | 3M CENTER, BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517374376 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SCOTCHCAST WET AND DRY CAST PADDING |
| Generic Name | (ITG) PROSTEHTIC AND ORTHOTIC ACCESS |
| Product Code | ITG |
| Date Received | 2012-12-27 |
| Model Number | NA |
| Catalog Number | WDP2 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-27 |