MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for NARROW TREATMENT RECLINER 3500000705 manufactured by Stryker Medical-kalamazoo.
[102457003]
It was reported that a patient was being moved from a bed onto the recliner via a ceiling lift. The recliner at the time was in the reclined position. From the user facility's internal investigation, it is believed that the patient was placed too far towards the head end of the recliner. This caused the recliner to lean backwards when patient weight was applied. The recliner did not tip, but the nurse on duty alleged that they had to push the recliner forward to avoid it from falling back. The nurse pushing forward allegedly caused the recliner to snap forward which caused the patient to complain that they were at "a 20 out of 10" in terms of pain. However, it was not reported if an injury was alleged or if any medical intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00143 |
| MDR Report Key | 7336415 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-13 |
| Date of Event | 2018-02-12 |
| Date Mfgr Received | 2018-02-15 |
| Device Manufacturer Date | 2012-02-27 |
| Date Added to Maude | 2018-03-13 |
| 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 | NARROW TREATMENT RECLINER |
| Generic Name | CHAIR, EXAMINATION AND TREATMENT |
| Product Code | FRK |
| Date Received | 2018-03-13 |
| Catalog Number | 3500000705 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-03-13 |