MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-08 for CATHETER GUIDE 343104 manufactured by Tfx Medical Inc..
[10355]
Patent was s/p radical prostatectomy, in the emergency room with c/o stricture of vesical neck, urologist attempting to insert foley catheter. During use of the filiform the female coupling separated from the filiform while attached to the male coupling of the follower being used (noted in d. 10. ). The incident resulted in the patient having to undergo outpatient surgery (cystoscopy) to remove the retained filiform.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16897 |
| MDR Report Key | 16897 |
| Date Received | 1994-07-08 |
| Date of Report | 1994-06-24 |
| Date of Event | 1993-12-30 |
| Date Facility Aware | 1993-12-30 |
| Report Date | 1994-06-24 |
| Date Reported to Mfgr | 1994-01-07 |
| Date Added to Maude | 1994-10-18 |
| 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 | CATHETER GUIDE |
| Generic Name | 4FR. URETHRAL FILIFORM SPIRAL TIP |
| Product Code | FBW |
| Date Received | 1994-07-08 |
| Catalog Number | 343104 |
| Lot Number | E 930510 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16830 |
| Manufacturer | TFX MEDICAL INC. |
| Manufacturer Address | 2450 MEADOWBROOK PARKWAY DULUTH GA 30136 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-08 |