FDA Adverse Event
Injury
Summary report: N
BAERVELDT SHUNT
MDR report key: 2725999
·
Received September 4, 2012
Report
- Report Number
- 2020664-2012-00064
- Event Type
- Injury
- Date Received
- September 4, 2012
- Date of Event
- February 17, 2012
- Report Date
- August 20, 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)(6). (B)(4) - BAERVELDT SHUNT. THE 510K NUMBER IS K955455. 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 AN IMPLANT OF A SHUNT. ON POST-OPERATIVE DAY ONE (1) THE PATIENT SHOWED HYPOTONY. POST-OPERATIVE DAY FIVE (5) IT WAS NOTED THAT THE PATIENT WAS RECOVERING FROM HYPOTONY. REPORTEDLY, NO COMPLICATIONS AROSE. IT WAS STATED THAT THIS REPORT WAS 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 |