MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-07-25 for 3M SCOTCHCAST PLUS CASTING TAPE 82002J manufactured by 3m Healthcare.
[883725]
The pt was treated in er for a fractured thumb with stockinet and web roll from bsn medical specialists and casting tape from 3m. About 23 hours later, the pt returned to er with fluid draining from the top of the cast. The cast was removed and the pt was diagnosed with a circumferential 2nd degree burn from the top of the cast to the palm. The pt was referred to a burn clinic for treatment with silvadene.
Patient Sequence No: 1, Text Type: D, B5
[8068047]
The device used was not returned to 3m for eval, however, manufacturing info of the lot is currently being reviewed. Initial reporter has also filed medwatch report. In summary, based on the info reported, 3m was not provided enough info to draw a conclusion if other factors contributed to the event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2008-00013 |
| MDR Report Key | 1082224 |
| Report Source | 05,06 |
| Date Received | 2008-07-25 |
| Date of Report | 2008-07-25 |
| Date of Event | 2008-07-03 |
| Date Mfgr Received | 2008-07-07 |
| Device Manufacturer Date | 2005-10-01 |
| Date Added to Maude | 2008-09-04 |
| 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 | RICA MORRIS, ASSOCIATE |
| Manufacturer Street | BLDG. 275-5W-06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517336791 |
| Manufacturer G1 | ALBA HEALTH |
| Manufacturer Street | 425 N GATEWAY BLVD |
| Manufacturer City | ROCKWOOD TN 37785 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37785 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M SCOTCHCAST PLUS CASTING TAPE |
| Generic Name | FIBERGLASS CAST MATERIALS |
| Product Code | ITG |
| Date Received | 2008-07-25 |
| Model Number | NA |
| Catalog Number | 82002J |
| Lot Number | 2010-10-FD |
| ID Number | NA |
| Device Expiration Date | 2010-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1050135 |
| Manufacturer | 3M HEALTHCARE |
| Manufacturer Address | 3M CENTER, BLDG. 275-5W-06 ST. PAUL MN 55144 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-07-25 |