MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-12-11 for 3M SCOTCHCAST SYNTHETIC CAST PADDING CMW02 manufactured by 3m Health Care.
[18224049]
A (b)(6) boy wearing a long arm cast that consisted of 3m stockinet, 3m synthetic cast padding, and ossur fiberglass had an allergic reaction to the casting material. The boy's mother said that he complained of itching a few days after wearing the cast. When the cast was removed 3 weeks later, the boy had blistery bleeding on the entire area under the cast and the stockinet was stuck to his skin. The boy was taken to see a dermatologist. The dermatologist determined that the boy was experiencing an allergic reaction and treated him with oral prednisone and a topical hydrocortisone cream. The cast was replaced with a removable air cast and the reaction was resolved within 48 hours.
Patient Sequence No: 1, Text Type: D, B5
[18359392]
Stockinet is manufactured by: alba health. (b)(4). 3m synthetic cast padding is a class i product. The boy's mother, (b)(6), indicated in her report that her son tends to have sensitive skin and is known to have reactions to sunscreens and chapstick. Based on the info reported, 3m believes that pt's history of skin sensitivity contributed to the adverse event. The device was not returned for further investigation, therefore, no further conclusions can be drawn. 3m will provide an updated report when further info is available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2009-00039 |
| MDR Report Key | 1560342 |
| Report Source | 05 |
| Date Received | 2009-12-11 |
| Date of Report | 2009-12-10 |
| Date of Event | 2009-10-14 |
| Date Mfgr Received | 2009-11-10 |
| Date Added to Maude | 2010-09-29 |
| 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 | 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 SYNTHETIC CAST PADDING |
| Generic Name | CAST PADDING |
| Product Code | ITG |
| Date Received | 2009-12-11 |
| Catalog Number | CMW02 |
| 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 | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-12-11 |