MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-19 for BURN SHEET 650-3001-0100 650-3001-00100 manufactured by Dukal Corporation.
[73250577]
The unit was falling apart when applied to a (b)(6)-old baby for second degree burns. The burn sheet adhered to the baby. When the burn sheet was tried to be removed, the skin came with it. The infant had to have the burn sheet surgically removed from his skin. Attempts to obtain the protocol used by the fire department have been unsuccessful to date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1422443-2017-00001 |
| MDR Report Key | 6504871 |
| Date Received | 2017-04-19 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-03-07 |
| Date Facility Aware | 2017-03-21 |
| Report Date | 2017-04-19 |
| Date Reported to FDA | 2017-04-19 |
| Date Reported to Mfgr | 2017-04-21 |
| Date Added to Maude | 2017-04-19 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURN SHEET |
| Generic Name | BURN SHEET |
| Product Code | FPY |
| Date Received | 2017-04-19 |
| Model Number | 650-3001-0100 |
| Catalog Number | 650-3001-00100 |
| Lot Number | JT36212 |
| Operator | EMERGENCY MEDICAL TECHNICIAN |
| Device Availability | N |
| Device Age | 50 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUKAL CORPORATION |
| Manufacturer Address | 2 FLEETWOOD COURT RONKONKOMA NY 11779 US 11779 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-19 |