MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-03-10 for 3M SCOTCHCAST WET OR DRY CAST PADDING WDP2 manufactured by 3m Healthcare.
[21992587]
This is class 1 product. Results, and conclusions- the device was not returned to 3m for evaluation, however, mfr's info was reviewed. Therefore no evaluation or conclusion regarding the quality of the device may be made. Based on the info and picture provided by the initial reporter, we believe the reaction may be scalded skin syndrome which is caused by an organism on the skin. However, the pt was only diagnosed and treated for burn. In summary, based on the info reported, 3m was not provided enough info to draw a conclusion if other factor contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
[22184494]
According to the initial reporter, the pt got the cast on sept. 17, 2008. About a week after the short arm cast was applied, the pt complained of itching. The cast was removed three weeks after it was applied. The pt was diagnosed with first and second degree burn, and was treated with triple antibiotic ointment and then with steroid. There was mold between the padding and the cast but it was not cultured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2009-00004 |
| MDR Report Key | 1343248 |
| Report Source | 04 |
| Date Received | 2009-03-10 |
| Date of Report | 2009-03-04 |
| Date of Event | 2008-10-10 |
| Date Mfgr Received | 2009-02-11 |
| Date Added to Maude | 2009-03-18 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | RICA MORRIS |
| 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 | ROGER CT 06263021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06263 0217 |
| Single Use | 0 |
| 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 | 2009-03-10 |
| Model Number | NA |
| Catalog Number | WDP2 |
| Lot Number | UNK |
| ID Number | NA |
| 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 HEALTHCARE |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-03-10 |