MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-10-12 for MOBILE TREAT. REC. LY5007 3300000020 NA manufactured by Stryker Medical.
[2998472]
It was reported by service report that the frame is broken on seat where backrest attaches. The customer reported that they did not know if there was any patient involvement or if there were adverse consequences to report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1831750-2012-10716 |
| MDR Report Key | 2835733 |
| Report Source | 07 |
| Date Received | 2012-10-12 |
| Date of Report | 2012-09-21 |
| Date of Event | 2012-09-21 |
| Date Mfgr Received | 2012-09-21 |
| Date Added to Maude | 2013-01-29 |
| 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 | MOBILE TREAT. REC. LY5007 |
| Generic Name | RECLINER |
| Product Code | FRJ |
| Date Received | 2012-10-12 |
| Model Number | 3300000020 |
| 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 | 2012-10-12 |