FDA Adverse Event
Malfunction
Summary report: N
SYNERGETICS BACKFLUSH HANDPIECE
MDR report key: 4906385
·
Received July 6, 2015
Report
- Report Number
- 1932402-2015-00007
- Event Type
- Malfunction
- Date Received
- July 6, 2015
- Date of Event
- June 11, 2015
- Report Date
- July 2, 2015
- Manufacturer
- SYNERGETICS, INC.
- Product Code
- HMX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO FILES ATTACHED.
Description of Event or Problem · 1
A PIECE OF THE BACKFLUSH HAND PIECE BROKE OFF AND WAS FLOATING IN THE RETINA. THE PIECE WAS RETRIEVED WITH NO ADVERSE IMPACT TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 437321 | SYNERGETICS BACKFLUSH HANDPIECE | BACKFLUSH HANDPIECE | HMX | SYNERGETICS, INC. | D31.08.25 | M477230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |