FDA Adverse Event
Injury
Summary report: N
BAERVELDT SHUNT
MDR report key: 2904436
·
Received January 9, 2013
Report
- Report Number
- 2020664-2013-00001
- Event Type
- Injury
- Date Received
- January 9, 2013
- Date of Event
- August 2, 2012
- Report Date
- December 17, 2012
- Manufacturer
- ABBOTT MEDICAL OPTICS
- Product Code
- KYF
- PMA / PMN Number
- K955455
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IN FOLLOW UP THE DOCTOR INDICATED HE DID NOT THINK THE DEVICE MALFUNCTIONED. ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURE HAS BEEN SUBMITTED.
Additional Manufacturer Narrative · 1
(B)(4). (B)(6). ALL PERTINENT INFORMATION AVAILABLE TO THE MANUFACTURER HAS BEEN SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD THE DEVICE IMPLANTED ON (B)(6) 2012. ON (B)(6) 2012 AT THE POSTOPERATIVE 3 MONTHS EXAMINATION, TUBE EROSION WAS OBSERVED. ON (B)(6), 2012, THE SHUNT IS EXPLANTED. THE HEALTH CARE PROFESSIONAL INDICATED THAT THE DEVICE DID NOT MALFUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10969 | BAERVELDT SHUNT | SURGICAL ADJUNCTS | KYF | ABBOTT MEDICAL OPTICS | BG103-250 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |