MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-04 for ALLEN UNK manufactured by Allen Medical Systems.
[441091]
While patient was positioned in stirrups for cysto; r stent insertion, left leg stirrup fell to floor and patient's left leg came out of stirrup. Patient's leg was returned to level position, another stirrup and holder were obtained and case continued. It was determined that the wrong attachment for the stirrup was used. No documentation of pain or injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 697054 |
| MDR Report Key | 697054 |
| Date Received | 2006-04-04 |
| Date of Report | 2006-03-30 |
| Date of Event | 2006-01-19 |
| Date Facility Aware | 2006-03-22 |
| Report Date | 2006-03-30 |
| Date Reported to FDA | 2006-03-30 |
| Date Reported to Mfgr | 2006-03-30 |
| Date Added to Maude | 2006-04-11 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | ALLEN |
| Generic Name | STIRRUP AND STIRRUP HOLDER |
| Product Code | BWN |
| Date Received | 2006-04-04 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 686163 |
| Manufacturer | ALLEN MEDICAL SYSTEMS |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-04-04 |