MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-18 for ISOFLEX LAL 2860 AFTERMARKET 2860000999 manufactured by Stryker Medical-kalamazoo.
[114287575]
A representative from the user facility advised they do not believe the device caused or contributed to the patient's skin breakdown. No malfunction was alleged.
Patient Sequence No: 1, Text Type: N, H10
[114287576]
It was reported that a patient had experienced a breakdown of the skin of the heel. No further information regarding the condition of the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00737 |
| MDR Report Key | 7697693 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-18 |
| Date of Report | 2018-07-18 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-06-19 |
| Date Added to Maude | 2018-07-18 |
| 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 LAL 2860 AFTERMARKET |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-07-18 |
| Catalog Number | 2860000999 |
| 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. Required No Informationntervention | 2018-07-18 |