FDA Adverse Event
Other
Summary report: N
SOS 23GA MEMBRANE SCRAPER
MDR report key: 2345629
·
Received November 18, 2011
Report
- Report Number
- 2529392-2011-00001
- Event Type
- Other
- Date Received
- November 18, 2011
- Date of Event
- October 18, 2011
- Report Date
- November 15, 2011
- Manufacturer
- PEREGRINE SURGICAL LTD.
- Product Code
- HQE
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
EVALUATION CONCLUDED THAT THIS REPORT WAS AN ISOLATED INCIDENCE AS IT WAS THE FIRST REPORT OF ITS KIND FOR THE (B)(4) PIECES OF THIS DEVICE DISTRIBUTED TO DATE.
Description of Event or Problem · 1
MEMBRANE SCRAPER IS USED DURING OPHTHALMIC SURGERY TO CREATE MEMBRANE EDGE ENABLING SURGEON TO PEEL BACK MEMBRANE AND EXPOSE TREATMENT AREA. THIS DEVICE WAS BEING USED DURING A PARS PLANA VITRECTOMY. DURING THE PROCEDURE IT WAS REPORTED THAT THE MEMBRANE SCRAPER HAD FLEX COME OFF INTO THE PATIENT'S EYE (THE SAPPHIRE CHIPS ADHERED TO SILICONE ROD). THE EYE WAS FLUSHED WITH FLUIDS TO REMOVE ALL REMAINING FLECKS OR CHIPS FROM THE PATIENT'S EYE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOS 23GA MEMBRANE SCRAPER | MEMBRANE SCRAPER | HQE | PEREGRINE SURGICAL LTD. | PD600.23 | 950523 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |