MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-08-24 for 3M SCOTCHCAST WPD2 2IN WET DRY CAST manufactured by 3m Health Care.
[18490057]
Customer reported a (b)(6), male, with a short arm cast developed redness and blistering with a diffuse macular, papular rash everywhere under the cast with a few worse spots and slight swelling and that removal of the stockinet deroofed the blisters. Reportedly the child got the cast wet in the pool, drained it, but it is unk whether the cast was flushed with tap water. Treatment was 2. 5 % hydrocortisone (prescription topical) and the reaction is resolving.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2010-00099 |
| MDR Report Key | 1818817 |
| Report Source | 06,07 |
| Date Received | 2010-08-24 |
| Date of Report | 2010-08-19 |
| Date of Event | 2010-07-28 |
| Date Mfgr Received | 2010-06-22 |
| Device Manufacturer Date | 2006-03-09 |
| Date Added to Maude | 2011-04-01 |
| 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 | HAMID IDRISSI |
| Manufacturer Street | BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517334934 |
| Manufacturer G1 | ROGERS CORP |
| Manufacturer Street | ONE TECHNOLOGY DRIVE P.O. BOX 217 |
| Manufacturer City | ROGERS CT 06263021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06263 0217 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2110898-07/22/010-002-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SCOTCHCAST WPD2 2IN WET DRY CAST |
| Generic Name | SCOTCHCAST |
| Product Code | ITG |
| Date Received | 2010-08-24 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | 2011-09-03 |
| Device Expiration Date | 2011-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | ST. PAUL MN 53144100 US 53144 1000 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-08-24 |