FDA Adverse Event
Injury
Summary report: N
BAERVELDT SHUNT
MDR report key: 2727200
·
Received September 5, 2012
Report
- Report Number
- 2020664-2012-00066
- Event Type
- Injury
- Date Received
- September 5, 2012
- Date of Event
- April 4, 2012
- Report Date
- August 7, 2012
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- KYF
- PMA / PMN Number
- K955455
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): PLACEHOLDER.
Additional Manufacturer Narrative · 1
(B)(4). 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. PLACEHOLDER.
Additional Manufacturer Narrative · 1
CORRECTION: THE PMA NUMBER IN THE FIRST FOLLOW-UP MDR IS BEING CORRECTED TO K955455. PLACEHOLDER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT IMPLANT OF THE SHUNT ON (B)(6), 2012. AT THE PATIENT'S POST OPERATIVE ONE (1) DAY VISIT, (B)(6), 2012, A VITREOUS HEMORRHAGE WAS OBSERVED. ON (B)(6), 2012, AT THE PATIENT'S POST-OPERATIVE ONE (1) WEEK VISIT, NO OBSERVATIONS OR COMPLICATIONS WERE REPORTED.
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 |