MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2000-04-21 for PORGES BOUGIE FILIFORM/FOLLOWER AG5R22 AG5M06 manufactured by Porges S.a..
[171935]
Filiform is alleged to have "broke" where the filiform and follower screw together. The complainant claims that the product had not been used (reprocessed) more than 10 times. Cystoscopy was claimed to have been performed to remove the broken part from the bladder with no injury or impact to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610711-2000-00001 |
| MDR Report Key | 278096 |
| Report Source | 08 |
| Date Received | 2000-04-21 |
| Date of Report | 2000-04-21 |
| Date of Event | 2000-03-15 |
| Date Mfgr Received | 2000-04-07 |
| Date Added to Maude | 2000-05-19 |
| 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 |
| Manufacturer Contact | DONALD GRABARZ |
| Manufacturer Street | MID VALLEY PROFESSIONAL PLAZA 7651 S. 700 WEST, STE 105 |
| Manufacturer City | SALT LAKE CITY UT 84047 |
| Manufacturer Country | US |
| Manufacturer Postal | 84047 |
| Manufacturer Phone | 8012220075 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORGES BOUGIE FILIFORM/FOLLOWER |
| Generic Name | URETHRAL DILATATION CATHETER |
| Product Code | FBW |
| Date Received | 2000-04-21 |
| Model Number | AG5R22 |
| Catalog Number | AG5M06 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 269183 |
| Manufacturer | PORGES S.A. |
| Manufacturer Address | CTR D'AFFAIRES LA BOURSIDIERE LE PLESSIS ROBINSON CEDEX FR 92357 |
| Baseline Brand Name | PORGES BOUGIE FILIFORM/FOLLOWER |
| Baseline Generic Name | URETHRAL DILATATION CATHETER |
| Baseline Model No | AG5R22 |
| Baseline Catalog No | AG5M06 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-04-21 |