MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-09-28 for DU PLASTER BDG XFST UNK. manufactured by Deroyal.
[170069]
A carapace product, (unable to confirm product number), after being wet down with extremely hot water was placed on pts leg. Pt complained of great pain far in excess of the pain from pt's broken leg, but was transferred to another facility approximately an hour away. When cast was removed at this facility, pt had 2nd and 3rd degree burns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1624487-2000-00003 |
| MDR Report Key | 298300 |
| Report Source | 07 |
| Date Received | 2000-09-28 |
| Date of Report | 2000-09-27 |
| Date of Event | 2000-08-30 |
| Report Date | 2000-09-27 |
| Date Reported to FDA | 2000-09-27 |
| Date Mfgr Received | 2000-09-13 |
| Date Added to Maude | 2000-10-03 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DU PLASTER BDG XFST |
| Generic Name | PLASTER BANDAGE |
| Product Code | LGF |
| Date Received | 2000-09-28 |
| Model Number | NA |
| Catalog Number | UNK. |
| Lot Number | UNK. |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 288747 |
| Manufacturer | DEROYAL |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | DU PLASTER BDG XFST |
| Baseline Generic Name | PLASTER BANDAGE |
| Baseline Model No | NA |
| Baseline Catalog No | UNK. |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-09-28 |