FDA Adverse Event
Injury
Summary report: N
BAERVELDT SHUNT
MDR report key: 2725982
·
Received September 4, 2012
Report
- Report Number
- 2020664-2012-00063
- Event Type
- Injury
- Date Received
- September 4, 2012
- Date of Event
- January 7, 2012
- Report Date
- August 7, 2012
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- KYF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - BAERVELDT SHUNT. (B)(4) - CHOROIDAL DETACHMENT. THE 510K NUMBER: K955455. THE DEVICE REMAINS IMPLANTED PRIOR TO RELEASE TO MARKET THE SHUNT MET ALL MANUFACTURING SPECIFICATIONS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT MEDICAL OPTICS HAS BEEN SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4): PLACEHOLDER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT OF A SHUNT. AT THE POST-OP WEEK ONE (1) VISIT, VITREOUS HEMORRHAGE AS WELL AS CHOROIDAL DETACHMENT WAS OBSERVED. THERE IS NO INFORMATION IF ANY INTERVENTION WAS CONDUCTED FOR THE EVENT. IT WAS STATED THAT IT IS NOT A COMPLAINT; HOWEVER, WAS A POST OPERATIVE COMPLICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BAERVELDT SHUNT | SURGICAL ADJUNCTS | KYF | ABBOTT MEDICAL OPTICS | BG102-350 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |