FDA Adverse Event
Injury
Summary report: N
SERISCAFFOLD SURGICAL SCAFFOLD (OUS)
MDR report key: 2875255
·
Received December 13, 2012
Report
- Report Number
- 3008374097-2012-00016
- Event Type
- Injury
- Date Received
- December 13, 2012
- Date of Event
- May 3, 2012
- Report Date
- May 24, 2012
- Manufacturer
- ALLERGAN
- Product Code
- FTL
- PMA / PMN Number
- K080442
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH SENT TO FDA ON (B)(4) 2012. DEVICE LABELING ADDRESSES THE REPORTED EVENT OF EXTRUSION AS FOLLOWS: "ADVERSE REACTIONS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS, INCLUDING INFECTION POTENTIATION, INFLAMMATION, ADHESION FORMATION, FISTULA FORMATION, AND EXTRUSION."
Description of Event or Problem · 1
PHYSICIAN REPORTED RIGHT SCAFFOLD EXPLANTATION DUE TO "BREAST IMPLANT EXTRUSION" FOR A PATIENT IN THE (B)(4) STUDY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SERISCAFFOLD SURGICAL SCAFFOLD (OUS) | FTL | ALLERGAN | NA | P2011062801A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Hospitalization| R | IMPLANT| IMPLANTED:| SECOND 410 COHESIVE SILICONE GEL FILLED BREAST| EXPLANTED:| FIRST 410 COHESIVE SILICONE GEL FILLED BREAST| IMPLANT| IMPLANTED:| PATIENT ONGOING CHEMOTHERAPY.| EXPLANTED: |