MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2010-12-10 for GYNNIE OB-GYN STRETCHER 1061 NA manufactured by Stryker Corp., Medical Div..
[1829859]
It was reported by service report that the headend won't lower from high height. No pt involvement or adverse consequences are reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1831750-2010-04746 |
| MDR Report Key | 1942769 |
| Report Source | 06,07 |
| Date Received | 2010-12-10 |
| Date of Report | 2010-11-01 |
| Date of Event | 2010-11-01 |
| Date Mfgr Received | 2010-11-01 |
| Device Manufacturer Date | 2010-06-15 |
| Date Added to Maude | 2011-02-08 |
| 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 | 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 | GYNNIE OB-GYN STRETCHER |
| Generic Name | HOSPITAL WHEELED STRETCHER |
| Product Code | HHP |
| Date Received | 2010-12-10 |
| Model Number | 1061 |
| 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 | 2010-12-10 |