MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-11-14 for DDV LIGATOR URETHRAL SOUND 17207094 manufactured by North American Medical, Inc..
[17429432]
While doing deep venous ligation during radical prostatectomy, the tip of the ligator broke cleanly off the tip of the sound. It was found in the bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1004011 |
| MDR Report Key | 17623 |
| Date Received | 1994-11-14 |
| Date of Report | 1994-11-01 |
| Date Added to Maude | 1994-11-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DDV LIGATOR URETHRAL SOUND |
| Generic Name | URETHRAL SOUND TO LIGATE DEEP VENOUS PLEXUS |
| Product Code | FBX |
| Date Received | 1994-11-14 |
| Returned To Mfg | 1994-09-30 |
| Model Number | 17207094 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17541 |
| Manufacturer | NORTH AMERICAN MEDICAL, INC. |
| Manufacturer Address | LUBBOCK TX 794644094 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-11-14 |