MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-12-15 for OB-GYN STRETCHER 1060 NA manufactured by Stryker Corp, Medical Div.
[1795194]
It was reported by service report that the head / foot jacks leaking hydraulic fluid. No patient involvement or adverse consequences are reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1831750-2010-04877 |
| MDR Report Key | 1958331 |
| Report Source | 06,07 |
| Date Received | 2010-12-15 |
| Date of Report | 2010-11-18 |
| Date of Event | 2010-11-18 |
| Date Mfgr Received | 2010-11-18 |
| Device Manufacturer Date | 1998-01-15 |
| Date Added to Maude | 2011-02-09 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 | 2693292100 |
| Manufacturer G1 | STRYKER CORP |
| 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 | OB-GYN STRETCHER |
| Generic Name | HOSPITAL WHEELED STRETCHER |
| Product Code | HHP |
| Date Received | 2010-12-15 |
| Model Number | 1060 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER CORP, MEDICAL DIV |
| Manufacturer Address | PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-15 |