MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-08-17 for ISOFLEX LAL 2860 2860000000 manufactured by Stryker Medical-kalamazoo.
[82944662]
It was reported the patient's skin broke down on the mattress. It was further reported that due to the patient's condition, the patient was forced to eat in bed. This was reportedly against standard hospital practices, and the wound care specialist stated this may have contributed to the patient injury. The wound care specialist also indicated that treatment was required, however no specific details were provided.
Patient Sequence No: 1, Text Type: D, B5
[91113123]
It was it was identified that the customer had assumed that isoflex lal (a gel support surface) was an air mattress rather than a gel mattress. It was identified that an air mattress may be better suited for this account's needs. The customer's isoflex lal units were replaced with isoair units (an air support surface). No device malfunction alleged.
Patient Sequence No: 1, Text Type: N, H10
[91113124]
It was reported the patient's skin broke down on the mattress. It was further reported that due to the patient's condition, the patient was forced to eat in bed. This was reportedly against standard hospital practices, and the wound care specialist stated this may have contributed to the patient injury. The wound care specialist also indicated that treatment was required, however no specific details were provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2017-00338 |
| MDR Report Key | 6801620 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-08-17 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-07-13 |
| Date Mfgr Received | 2017-07-20 |
| Date Added to Maude | 2017-08-17 |
| 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. MARY KLAVER |
| 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 LAL 2860 |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2017-08-17 |
| Catalog Number | 2860000000 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-08-17 |