MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-06-30 for ISOFLEX MEDSURG MATTRESS MODEL 2800100997 NA manufactured by Stryker Corp Dba Gaymar.
[2119731]
It was reported that a pt recently developed an unstageable pressure ulcer.
Patient Sequence No: 1, Text Type: D, B5
[9197854]
Customer has been unresponsive to multiple attempts at obtaining additional info on this reported event. F/u will be filed as necessary based upon investigations results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1313850-2011-00157 |
| MDR Report Key | 2158100 |
| Report Source | 06 |
| Date Received | 2011-06-30 |
| Date of Report | 2011-06-02 |
| Date of Event | 2011-06-01 |
| Date Mfgr Received | 2011-06-02 |
| Device Manufacturer Date | 2004-03-15 |
| Date Added to Maude | 2011-07-15 |
| 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 | RENATA SILA |
| Manufacturer Street | 3800 EAST CENTRE AVE. |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693896689 |
| Manufacturer G1 | STRYKER CORP DBA GAYMAR |
| Manufacturer Street | 10 CENTRE DR. |
| Manufacturer City | ORCHARD PARK NY 14127 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 14127 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOFLEX MEDSURG MATTRESS MODEL |
| Generic Name | MATTRESS |
| Product Code | FOH |
| Date Received | 2011-06-30 |
| Model Number | 2800100997 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP DBA GAYMAR |
| Manufacturer Address | ORCHARD PARK NY 14127 US 14127 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-30 |