MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-26 for NARROW TREATMENT RECLINER 3500000705 manufactured by Stryker Medical-kalamazoo.
[115362843]
It was reported that a patient fell after leaning forward from a reclined position. The back rest was not locked, causing unexpected motion. The patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
[117742480]
Updated to add investigation information. Device not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[117742481]
It was reported that a patient fell after leaning forward from a reclined position. The back rest was not locked, causing unexpected motion. The patient was not injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001831750-2018-00902 |
| MDR Report Key | 7723779 |
| Date Received | 2018-07-26 |
| Date of Report | 2018-08-10 |
| Date of Event | 2018-06-28 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-07-26 |
| 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 | 0 |
| Brand Name | NARROW TREATMENT RECLINER |
| Generic Name | CHAIR, EXAMINATION AND TREATMENT |
| Product Code | FRK |
| Date Received | 2018-07-26 |
| Catalog Number | 3500000705 |
| 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 | 2018-07-26 |