MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-07-29 for INMED UNK * manufactured by Inmed Corp..
[21710142]
Physician attempted to dilate urethra. Filiform and followers used to bypass and dilate urethral stricture. Filiform broken and retained in the urethra. Pathology report shows 29 cm long segment of plastic wire with mfr's label.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 54938 |
| MDR Report Key | 54938 |
| Date Received | 1996-07-29 |
| 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 | 1996-12-13 |
| 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 | INMED |
| Generic Name | PHILIPS FOLLOWER - FILIFORM CATHETER |
| Product Code | FBW |
| Date Received | 1996-07-29 |
| Model Number | UNK |
| Catalog Number | * |
| Lot Number | 931119 |
| ID Number | 931119 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 55487 |
| Manufacturer | INMED CORP. |
| Manufacturer Address | * NORCROSS GA 30071 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-07-29 |