MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-17 for PORGES NEOPLEX UNK manufactured by Mentor-porges.
[319125]
Add'l info rec'd from mfr 7/7/04: as no more precise info was available, company has had to suppose that the reference of the device is ag5002, the batch number remains unk. Unfortunately no device is available for eval. Therefore company could not perform any analysis. This incident is the first one reported with the product referenced ag5002. Conclusion: no eval. Possible.
Patient Sequence No: 1, Text Type: D, B5
[19961240]
A urethral dilatation was attempted using filiforms and followers. After several attempts the last 2 inches of the filiform fell out of the urethra leaving the remaining 10-12 inches inside the pt. Attempts to retrieve the piece was unsuccessful. Pt required a cystoscopy for removal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1031882 |
| MDR Report Key | 523384 |
| Date Received | 2004-03-17 |
| Date of Report | 2004-03-01 |
| Date of Event | 2004-02-24 |
| Date Added to Maude | 2004-05-05 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORGES NEOPLEX |
| Generic Name | FILIFORM |
| Product Code | FBW |
| Date Received | 2004-03-17 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 512516 |
| Manufacturer | MENTOR-PORGES |
| Manufacturer Address | CENTRE D'AFFAIRES LABOURSIDIER LE PLESSIS-ROBINSON CEDEX FR 92 357 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-03-17 |