FDA Adverse Event
Injury
Summary report: N
STYLE 133SV TISSUE EXPANDER
MDR report key: 8685090
·
Received June 10, 2019
Report
- Report Number
- 9617229-2019-06675
- Event Type
- Injury
- Date Received
- June 10, 2019
- Report Date
- June 10, 2019
- Manufacturer
- ALLERGAN (COSTA RICA)
- Product Code
- LCJ
- PMA / PMN Number
- K862203
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OF INFECTION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE REASON FOR REOPERATION IS INFECTION. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.
Description of Event or Problem · 1
PATIENT REPORTED RIGHT SIDE HAD INFECTION AND EXPANDER EXPLANTED, CLEANED AND RE-IMPLANTED ON (B)(6) 2018. DEVICE HAS BEEN EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 475987 | STYLE 133SV TISSUE EXPANDER | EXPANDER, SKIN, INFLATABLE | LCJ | ALLERGAN (COSTA RICA) | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |