MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-04-09 for XPRT SLEEP SURFACE 2950000000 manufactured by Stryker Medical-kalamazoo.
[3416074]
It was reported via repair work order that the mattress had fluid intrusion due to peeling and delamination. No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
Patient Sequence No: 1, Text Type: D, B5
[10614270]
Mattress cover was replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001831750-2013-03040 |
| MDR Report Key | 3043519 |
| Report Source | 00,06 |
| Date Received | 2013-04-09 |
| Date of Report | 2013-03-15 |
| Date of Event | 2013-03-15 |
| Date Mfgr Received | 2013-03-15 |
| Date Added to Maude | 2013-06-06 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. PRAVIN BETALA |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693292100 |
| Manufacturer G1 | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPRT SLEEP SURFACE |
| Generic Name | COVER, MATTRESS (MEDICAL PURPOSES) |
| Product Code | FMW |
| Date Received | 2013-04-09 |
| Catalog Number | 2950000000 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL-KALAMAZOO |
| Manufacturer Address | 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-09 |