MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-11 for ISOGEL AIR 2860-000-001 manufactured by Stryker Medical.
[79612729]
Patient Sequence No: 1, Text Type: N, H10
[79612730]
Mattress covers are delaminating on the underside allowing fluids to potentially enter the body of the mattress; due to the design of the internal components- cleaning can not be properly completed with potential risk for patient exposure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6700475 |
| MDR Report Key | 6700475 |
| Date Received | 2017-07-11 |
| Date of Report | 2017-06-30 |
| Date of Event | 2017-06-20 |
| Report Date | 2017-06-30 |
| Date Reported to FDA | 2017-06-30 |
| Date Reported to Mfgr | 2017-06-30 |
| Date Added to Maude | 2017-07-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ISOGEL AIR |
| Generic Name | COVER, MATTRESS (MEDICAL PURPOSES) |
| Product Code | FMW |
| Date Received | 2017-07-11 |
| Model Number | 2860-000-001 |
| Catalog Number | 2860-000-001 |
| Lot Number | 144346, 144347 |
| Device Availability | N |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL |
| Manufacturer Address | 3800 E. CENTRE AVENUE PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-11 |