MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-30 for ISOFLEX LAL,2860, W/MEDSURG 2860000997 manufactured by Stryker Medical-kalamazoo.
[115650698]
No device malfunction alleged and no sn was recorded.
Patient Sequence No: 1, Text Type: N, H10
[115650699]
It was reported a radiology staff member injured her wrist pushing an x-ray cassette into place on the mattress by herself. The extent of the reported injury is not known. There was patient involvement, however no adverse consequence or impact to the patient was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00908 |
| MDR Report Key | 7733327 |
| Date Received | 2018-07-30 |
| Date of Report | 2018-07-30 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-07-02 |
| Date Added to Maude | 2018-07-30 |
| 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 | 0 |
| Brand Name | ISOFLEX LAL,2860, W/MEDSURG |
| Generic Name | BED, FLOTATION THERAPY, POWERED |
| Product Code | IOQ |
| Date Received | 2018-07-30 |
| 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 | 2018-07-30 |