MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-07-27 for PATIENT ROOM WALL SAVER RECL 3500000730 NA manufactured by Stryker Medical.
[2736439]
It was reported by service report that the customer alleged when the patient was getting up from the recliner, the foot section did not latch and the patient fell. There was patient involvement but no adverse consequences were confirmed by the user facility. The patient did not require medical intervention as a result of the alleged incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1831750-2012-07865 |
| MDR Report Key | 2676840 |
| Report Source | 06,07 |
| Date Received | 2012-07-27 |
| Date of Report | 2012-06-29 |
| Date of Event | 2012-06-29 |
| Date Mfgr Received | 2012-06-29 |
| Date Added to Maude | 2012-08-02 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RENATA SILA |
| Manufacturer Street | 3800 E. CENTRE AVE. |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693896689 |
| Manufacturer G1 | STRYKER MEDICAL |
| Manufacturer Street | 3800 E. CENTRE AVE. |
| 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 | PATIENT ROOM WALL SAVER RECL |
| Generic Name | RECLINER |
| Product Code | FRJ |
| Date Received | 2012-07-27 |
| Model Number | 3500000730 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL |
| Manufacturer Address | PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-07-27 |