MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-17 for ISOFLEX W BX 80 OPT CVR INTL 2860 2860000026 manufactured by Stryker Medical-kalamazoo.
[179920979]
It was reported that a patient suffered pressure injuries on their abdomen. The wounds were treated with special wound dressings. The customer is not alleging the mattress caused or contributed directly to the injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2020-00302 |
| MDR Report Key | 9717292 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. KRISTEN CANTER |
| 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 W BX 80 OPT CVR INTL |
| Generic Name | MATTRESS, FLOTATION THERAPY, NON-POWERED |
| Product Code | IKY |
| Date Received | 2020-02-17 |
| Model Number | 2860 |
| Catalog Number | 2860000026 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2020-02-17 |