MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2014-10-13 for MATTRESS COVER FOR MEDICAL PURPOSES 5185 manufactured by Unknown.
[19971461]
The end-user states his mom bought the bed a few years ago. He alleges the mattress may have been previously used or they received a defective mattress.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2014-04841 |
| MDR Report Key | 4166112 |
| Report Source | * |
| Date Received | 2014-10-13 |
| Date of Report | 2014-09-24 |
| Date Facility Aware | 2014-09-24 |
| Report Date | 2014-10-11 |
| Date Reported to FDA | 2014-10-11 |
| Date Reported to Mfgr | 2014-10-11 |
| Date Added to Maude | 2014-10-13 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MATTRESS COVER FOR MEDICAL PURPOSES |
| Generic Name | 880.6190 |
| Product Code | FMW |
| Date Received | 2014-10-13 |
| Model Number | 5185 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-13 |