MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-12-20 for TREATMENT RECLINER 3500000710 NA manufactured by Stryker Medical.
[3372507]
It was reported by service report that there was a damaged right arm rest with reported sharp edges. No pt involvement or adverse consequences are reported.
Patient Sequence No: 1, Text Type: D, B5
[10452780]
Result: arm rest.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1831750-2012-13230 |
| MDR Report Key | 2916151 |
| Report Source | 07 |
| Date Received | 2012-12-20 |
| Date of Report | 2012-12-14 |
| Date of Event | 2012-12-14 |
| Date Mfgr Received | 2012-12-14 |
| Date Added to Maude | 2013-03-21 |
| 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 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693896689 |
| Manufacturer G1 | STRYKER MEDICAL |
| 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 | 3 |
| Brand Name | TREATMENT RECLINER |
| Generic Name | RECLINER |
| Product Code | FIA |
| Date Received | 2012-12-20 |
| Model Number | 3500000710 |
| 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 | 2012-12-20 |