FDA Adverse Event
Injury
Summary report: N
ASSEMBLY, 9300XSP L/S W/AWOS T
MDR report key: 3970978
·
Received July 8, 2014
Report
- Report Number
- 1222895-2014-00012
- Event Type
- Injury
- Date Received
- July 8, 2014
- Report Date
- June 20, 2014
- Manufacturer
- INTEGRA BURLINGTON, MA, INC.
- Product Code
- GCT
- PMA / PMN Number
- K864385
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
CUSTOMER INITIALLY REPORTS THAT A PATIENT WAS MILDLY BURNED DURING PROCEDURE. PATIENT IS FINE. CUSTOMER NOT SURE IF RETRACTOR WAS USED IN SURGERY. ON (B)(6) 2014 CUSTOMER PROMISED TO ANSWER EMAIL QUESTIONS, MULTIPLE REQUESTS MADE, BUT NO RESPONSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397873 | ASSEMBLY, 9300XSP L/S W/AWOS T | 300WLS | GCT | INTEGRA BURLINGTON, MA, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | P895FO FERREIRA BREAST RETRACTOR W/FIBER OPTICS |