FDA Adverse Event
Other
Summary report: N
INTEXEN LP
MDR report key: 1464374
·
Received September 2, 2009
Report
- Report Number
- 2183959-2009-00064
- Event Type
- Other
- Date Received
- September 2, 2009
- Date of Event
- June 23, 2009
- Report Date
- September 1, 2009
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- PMA / PMN Number
- K050445
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED ON 8/10/2009, INDICATES THAT ON (B) (6) 2009, A SURGERY OCCURRED AND THE PT WAS IMPLANTED WITH OUR INTEXEN MATERIAL AND SHE IS NOT PRESENTING WITH ITCHY RASHES ON HER TOES AND HANDS (ALLERGIC REACTION). A REVISION SURGERY HAS NOT BEEN DETERMINED AT THIS TIME; AND AMS HAS REQUESTED ADD'L INFO AND NO FURTHER INFO HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEXEN LP | PORCINE DERMAL MATRIX | FTL | AMERICAN MEDICAL SYSTEMS, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |