MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-04-02 for PHILIPS FOLLOWER - FILIFORM CATHETER UNKNOWN manufactured by Inmed Corp..
[18574]
Physician attempted to dilate urethra. Filiform and followers used to bypass and dilate urethral stricture. Filiform broken and retained in the urethra. Pathology report - 29 cm long segment of plastic wire.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 32975 |
| MDR Report Key | 32975 |
| Date Received | 1996-04-02 |
| Date of Report | 1996-04-01 |
| Date of Event | 1996-03-19 |
| Date Facility Aware | 1996-03-22 |
| Report Date | 1996-04-01 |
| Date Reported to FDA | 1996-04-01 |
| Date Reported to Mfgr | 1996-04-01 |
| Date Added to Maude | 1996-05-17 |
| 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 |
| 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 | PHILIPS FOLLOWER - FILIFORM CATHETER |
| Generic Name | FILIFORM CATHETER |
| Product Code | FBW |
| Date Received | 1996-04-02 |
| Model Number | UNKNOWN |
| Lot Number | 931119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 34274 |
| Manufacturer | INMED CORP. |
| Manufacturer Address | NORCROSS GA 30071 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-04-02 |