FDA Adverse Event
Injury
Summary report: N
APOGEE
MDR report key: 1902542
·
Received November 12, 2010
Report
- Report Number
- 2183959-2010-00417
- Event Type
- Injury
- Date Received
- November 12, 2010
- Report Date
- November 1, 2010
- Manufacturer
- AMERICAN MEDICAL SYSTEMS, INC.
- Product Code
- FTL
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
INFO SUGGESTS THE SLING HAS NOT BEEN REMOVED. NO CONCLUSION CAN BE DRAWN BASED ON THE INFO PROVIDED. SHOULD ADDITIONAL INFO BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.
Description of Event or Problem · 1
RELATED TO 2183959-2010-00414, 2183959-2010-00416. PT WAS IMPLANTED WITH APOGEE ON (B)(6) 2005. PT CLAIMS THAT AFTER, AND AS A RESULT OF, THE IMPLANTATION SHE HAS SUFFERED SERIOUS BODILY INJURIES, EXTREME PAIN, EROSION OF HER INTERNAL BODILY TISSUE, MENTAL PAIN AND SHE HAS SUSTAINED PERMANENT INJURY. NO FURTHER INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APOGEE | SURGICAL MESH | FTL | AMERICAN MEDICAL SYSTEMS, INC. | NI | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Disability | MONARC| PERIGEE |