MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-03-22 for ISOFLEX 35X84X6 NYLON 2800100010 manufactured by Stryker Medical-kalamazoo.
[16217366]
It was alleged by the customer that they have seen patients develop pressure ulcers while using an isoflex mattress. However, as the customer stated they did not record any serial numbers for the reported pressure ulcers found on their isoflex mattresses, it is not known if this mattress is alleged to have caused or contributed to a pressure ulcer development.
Patient Sequence No: 1, Text Type: D, B5
[16577266]
Customer provided with a new mattress
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001831750-2013-02326 |
| MDR Report Key | 3017736 |
| Report Source | 05 |
| Date Received | 2013-03-22 |
| Date of Report | 2013-02-26 |
| Date of Event | 2013-02-26 |
| Date Mfgr Received | 2013-02-26 |
| Date Added to Maude | 2013-03-22 |
| 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 | 3 |
| 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 | ISOFLEX 35X84X6 NYLON |
| Generic Name | COVER, MATTRESS (MEDICAL PURPOSES) |
| Product Code | FMW |
| Date Received | 2013-03-22 |
| Catalog Number | 2800100010 |
| 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 | 2013-03-22 |