MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-06-30 for MOBILE TREAT. REC. LY1007 3300000007 NA manufactured by Stryker Corp, Medical Division.
[18837220]
It was reported that the recliner has a broken mechanism and an upholstery tear where the mechanism appears to have come through the fabric. The ottoman will close, but half of it could not support weight as it was tilted to one side.
Patient Sequence No: 1, Text Type: D, B5
[18909047]
Na.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1831750-2010-01385 |
| MDR Report Key | 1756527 |
| Report Source | 07 |
| Date Received | 2010-06-30 |
| Date of Report | 2010-06-10 |
| Date of Event | 2010-06-10 |
| Date Mfgr Received | 2010-06-10 |
| Device Manufacturer Date | 2005-06-15 |
| Date Added to Maude | 2010-09-23 |
| 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 | 2693246689 |
| Manufacturer G1 | STRYKER CORP |
| Manufacturer Street | 3800 EAST CENTRE AVENUE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49002 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MOBILE TREAT. REC. LY1007 |
| Generic Name | EXAMINATION AND TREATMENT CHAIR |
| Product Code | ETF |
| Date Received | 2010-06-30 |
| Model Number | 3300000007 |
| Catalog Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP, MEDICAL DIVISION |
| Manufacturer Address | PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-30 |