MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1999-05-18 for UNK NI manufactured by M-pact.
[128751]
Pt being fitted for a pliable back brace when she sustained second- and third-degree burns on the right side of her body.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1928508-1999-00001 |
| MDR Report Key | 224277 |
| Report Source | 00 |
| Date Received | 1999-05-18 |
| Date of Report | 1999-04-26 |
| Date of Event | 1998-07-30 |
| Date Mfgr Received | 1999-03-26 |
| Date Added to Maude | 1999-05-24 |
| 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 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | REPORTED AS PLASTER BANDAGE |
| Product Code | LGF |
| Date Received | 1999-05-18 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | UNK IF M-PACT DEVICE |
| Operator | NO INFORMATION |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 217482 |
| Manufacturer | M-PACT |
| Manufacturer Address | 1040 OCL PARKWAY EUDORA KS 66025 US |
| Baseline Brand Name | UNK |
| Baseline Generic Name | REPORTED AS PLASTER BANDAGE |
| Baseline Model No | NI |
| Baseline Catalog No | NI |
| Baseline ID | UNK IF M-PACT D |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-05-18 |