MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-04-30 for OVERHEAD TRAPEZE FA64148 NA manufactured by Stryker Medical Quebec, Lp.
[1493803]
It has been reported that the pt helper broke free and hit pt. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680128-2010-00028 |
| MDR Report Key | 1674457 |
| Report Source | 07 |
| Date Received | 2010-04-30 |
| Date of Report | 2010-04-01 |
| Date of Event | 2010-04-01 |
| Date Mfgr Received | 2010-04-01 |
| Date Added to Maude | 2010-05-21 |
| 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 E CENTRE AVE |
| Manufacturer City | PORTAGE MI 49002 |
| Manufacturer Country | US |
| Manufacturer Postal | 49002 |
| Manufacturer Phone | 2693246689 |
| Manufacturer G1 | STRYKER MEDICAL QUEBEC, LP |
| Manufacturer Street | 230, NILUS-LECLERC BLVD |
| Manufacturer City | L'LSLET, QUEBEC G0R2C0 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | G0R 2C0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OVERHEAD TRAPEZE |
| Generic Name | ACCESSORY |
| Product Code | ILZ |
| Date Received | 2010-04-30 |
| Model Number | FA64148 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL QUEBEC, LP |
| Manufacturer Address | L'LSLET, QUEBEC G0R2C0 CA G0R 2C0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-30 |