MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-11-05 for DEFLUX IMPLANT manufactured by Salix Pharmaceutical Inc.
[3849011]
A mother called to report that her daughter was implanted with a deflux implant, a gel that is injected into the urethra to stop urine from flowing back up into the ureter. After 48 hours of being injected the pt experienced severe abdominal pain, bladder spasm, and a torn bladder. The pt had a reaction to the product. The pt bleed for 4-5 days after the implant. The surgery was performed by one doctor (b)(6). The mother consulted with doctor (b)(6), family urologists, who repaired the daughter's damaged bladder but was not able to remove/flush out the implanted gel. The mother called to inquire if fda will be able to remove/flush out the implanted gel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5032560 |
| MDR Report Key | 3455573 |
| Date Received | 2013-11-05 |
| Date of Report | 2013-09-18 |
| Date of Event | 2013-06-11 |
| Date Added to Maude | 2013-11-08 |
| 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 | 0 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEFLUX IMPLANT |
| Generic Name | INJECTABLE GEL |
| Product Code | LMN |
| Date Received | 2013-11-05 |
| Operator | OTHER |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SALIX PHARMACEUTICAL INC |
| Manufacturer Address | 8150 COLONNADE CENTER DRIVE RALEIGH NC 27615 US 27615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-11-05 |