MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1998-11-05 for LEFORT URETHRAL SOUND 24 FR. GU4050-024 manufactured by Allegiance Healthcare Corp..
[143343]
The filiform has broken off the tip of the sound, during a suprapubic cystotomy procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-1998-00327 |
| MDR Report Key | 195703 |
| Report Source | 05,06 |
| Date Received | 1998-11-05 |
| Date of Report | 1998-11-05 |
| Date of Event | 1998-10-13 |
| Date Mfgr Received | 1998-10-13 |
| Device Manufacturer Date | 1978-01-01 |
| Date Added to Maude | 1998-11-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEFORT URETHRAL SOUND 24 FR. |
| Generic Name | INSTRUMENT |
| Product Code | FBX |
| Date Received | 1998-11-05 |
| Returned To Mfg | 1998-10-26 |
| Model Number | GU4050-024 |
| Catalog Number | GU4050-024 |
| Lot Number | DI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 190133 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | LEFORT URETHRAL SOUND 24 FR |
| Baseline Generic Name | INSTRUMENT |
| Baseline Model No | GU4050-024 |
| Baseline Catalog No | GU4050-024 |
| Baseline ID | NA |
| Baseline Device Family | INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-11-05 |