MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-12 for MINOR SURGERY STRETCHER 678000 * manufactured by Hausted.
[76435]
Pt was placed on a surgical cart in a moderate trendelendburg position. The physician experienced some difficulty in performing the procedure during surgery. The physician noted the cart had changed position from the initial setting (after the procedure). Pt required more time in the or & may need add'l retinal surgery to improve pt's eye sight.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 138328 |
| MDR Report Key | 138328 |
| Date Received | 1997-12-12 |
| Date of Report | 1997-12-10 |
| Date of Event | 1997-12-01 |
| Date Facility Aware | 1997-12-01 |
| Report Date | 1997-12-10 |
| Date Reported to FDA | 1997-12-12 |
| Date Reported to Mfgr | 1997-12-12 |
| Date Added to Maude | 1997-12-18 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINOR SURGERY STRETCHER |
| Generic Name | OR./CATARACT CART |
| Product Code | FWW |
| Date Received | 1997-12-12 |
| Model Number | 678000 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 9 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 135089 |
| Manufacturer | HAUSTED |
| Manufacturer Address | 927 LAKE RD. MEDINA OH 442580710 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-12-12 |