MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2008-05-06 for CUSHION GRIP NA manufactured by Schering-plough.
[854649]
A lawyer reported a female consumer used cushion grip and orafix. He reported as a results she sustained severe, permanent and disabling injuries including acute myelogenous leukemia from which she died in 2005. No additional info was provided.
Patient Sequence No: 1, Text Type: D, B5
[8001090]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020060-2007-00001 |
| MDR Report Key | 1036866 |
| Report Source | 04 |
| Date Received | 2008-05-06 |
| Date of Report | 2006-05-21 |
| Date of Event | 2005-04-11 |
| Date Mfgr Received | 2006-05-21 |
| Date Added to Maude | 2008-05-08 |
| 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 | 0 |
| Manufacturer Street | 3030 JACKSON AVE. |
| Manufacturer City | MEMPHIS TN 38151 |
| Manufacturer Country | US |
| Manufacturer Postal | 38151 |
| Manufacturer Phone | 9013202421 |
| Manufacturer G1 | SCHERING-PLOUGH |
| Manufacturer Street | 13900 NW 57TH COURT |
| Manufacturer City | MIAMI LAKES FL 33014310 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 3103 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSHION GRIP |
| Generic Name | ORAL PASTE |
| Product Code | KOP |
| Date Received | 2008-05-06 |
| Catalog Number | NA |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1006020 |
| Manufacturer | SCHERING-PLOUGH |
| Manufacturer Address | MIAMI LAKES FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-05-06 |