MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-10-26 for 3M SCOTCHCAST WET OR DRY CAST PADDING WDP2 manufactured by 3m Health Care.
[19286607]
A female pt wearing a short arm wet or dry type cast developed maceration. The physician assistant gave the pt instructions as to how to care for the cast. When the pt came in to get the cast removed, he noticed that the stockinet was still wet and the pt had an infection. The skin was red with little white balls. He treated her infection with an oral antibiotic called keflex.
Patient Sequence No: 1, Text Type: D, B5
[19342018]
The 3m scotchcast wet dry padding is a class i product. The pt info sheet provides instructions and precautions for cast care. If your physician permits you to get your cast wet, you must allow the cast and your skin to dry thoroughly before getting the cast wet again. If you experience maceration (i. E. , softened, white or wrinkled skin), skin irritation, heat rash or pain, do not get the cast wet. If the cast is wet, a pt must allow the cast and the skin to dry thoroughly before getting the cast wet again to prevent maceration, skin irritation, heat rash (miliaria) and possible infection. A pt should be carefully instructed in the necessity of thoroughly drying the cast. Based on the info reported, 3m was not provided enough info to draw a conclusion if other factors contributed to the events. A 3m will provide an updated report when further info is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2009-00030 |
| MDR Report Key | 1519047 |
| Report Source | 05 |
| Date Received | 2009-10-26 |
| Date of Report | 2009-10-22 |
| Date of Event | 2009-09-09 |
| Date Mfgr Received | 2009-09-24 |
| Date Added to Maude | 2010-10-13 |
| 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 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MELISSA FRANK, ASSOCIATE |
| Manufacturer Street | BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517336791 |
| Manufacturer G1 | ROGERS CORP |
| Manufacturer Street | ONE TECHNOLOGY DR |
| Manufacturer City | ROGERS CT 06263021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06263 0217 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SCOTCHCAST WET OR DRY CAST PADDING |
| Generic Name | CAST PADDING |
| Product Code | ITG |
| Date Received | 2009-10-26 |
| Catalog Number | WDP2 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-26 |