MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-05 for GAYMAR ISOFLEX CRITICARE MATT MODEL MATTRESS 2800100998 manufactured by Stryker Corp.
[3686655]
To whom it may concern, in regards to below issue, we have the same mattresses in our facility, and we are concern what the next step might be in resolving this issue. Stryker rep has been contacted. Please advise, thank you. It was reported by service report that there has been fluid intrusion to the interior mattress. No pt involvement or adverse consequences are reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030850 |
| MDR Report Key | 3224306 |
| Date Received | 2013-07-05 |
| Date of Report | 2013-06-05 |
| Date of Event | 2012-10-24 |
| Date Added to Maude | 2013-07-15 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GAYMAR ISOFLEX CRITICARE MATT MODEL MATTRESS |
| Generic Name | MATTRESS |
| Product Code | FMW |
| Date Received | 2013-07-05 |
| Model Number | 2800100998 |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-05 |