MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-04-09 for ISOFLEX LAL,2860, W/MEDSURG 2860000997 manufactured by Stryker Medical-kalamazoo.
[104659853]
The serial number of the unit involved in the alleged event was not recorded, therefore no evaluation could be performed. However, the account was not alleging a product malfunction. Rather, the nurse manager indicated they believe the event occurred due to the patient not being rotated/turned frequently enough. Serial number of unit involved in alleged event was not recorded.
Patient Sequence No: 1, Text Type: N, H10
[104659854]
It was reported the patient developed a deep tissue injury on the lower spine area which required medication. No additional information regarding medical intervention was reported. The nurse manager at the account reported they attributed the alleged injury to the patient not being turned enough.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00195 |
| MDR Report Key | 7406247 |
| Report Source | USER FACILITY |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-09 |
| Date of Event | 2018-03-13 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-04-09 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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, W/MEDSURG |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-04-09 |
| Catalog Number | 2860000997 |
| 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 | 2018-04-09 |