MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1997-05-08 for UNK manufactured by Rusch Mfg. Uk, Ltd..
[60279]
While the physician was performing a procedure, the female thread either broke or detached from the brass part and this part fell into the bladder. The part was retrieved with no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010092-1997-00043 |
| MDR Report Key | 90244 |
| Report Source | 05,06 |
| Date Received | 1997-05-08 |
| Date of Report | 1997-05-08 |
| Date of Event | 1997-05-07 |
| Date Mfgr Received | 1997-05-07 |
| Date Added to Maude | 1997-05-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK |
| Generic Name | FILIFORM |
| Product Code | FBW |
| Date Received | 1997-05-08 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | 952108 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 89201 |
| Manufacturer | RUSCH MFG. UK, LTD. |
| Manufacturer Address | PORTADOWN RD. INDUSTRIAL ESTATE LURGAN EI BT66 8RD |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-05-08 |