FDA Adverse Event
Malfunction
Summary report: N
STORZ BENGER PROBE HOOK
MDR report key: 4026966
·
Received August 18, 2014
Report
- Report Number
- 4026966
- Event Type
- Malfunction
- Date Received
- August 18, 2014
- Date of Event
- July 1, 2014
- Report Date
- July 28, 2014
- Manufacturer
- BAUSCH & LOMB INC.
- Product Code
- HNW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH, US
Narratives
Description of Event or Problem · 1
DURING THE TDP (TEAR DUCT PROBE) PROCEDURE, THE PHYSICIAN HAD A CROCHET HOOK IN THE SET BREAK AT THE TIP WHILE IT WAS INSIDE THE NOSE OF THE PATIENT. THE OBJECT WAS REMOVED AND FOLLOWED UP WITH X-RAY. XRAY CLEAR: NO RETAINED INSTRUMENT.THIS IS THE FOURTH EVENT REPORTED WITH THIS MEDICAL DEVICE AT THIS FACILITY WITHIN APPROXIMATELY 6 MONTHS. STAFF/PHYSICIANS DO NOT KNOW WHAT IS CAUSING THE EVENTS TO OCCUR. THE MANUFACTURER HAS BEEN NOTIFIED AND PRODUCT HAS BEEN RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 496344 | STORZ BENGER PROBE HOOK | PROBE, LACRYMAL | HNW | BAUSCH & LOMB INC. | E4222 | * | |
| 496345 | STORZ BENGER PROBE HOOK | PROBE, LACRYMAL | HNW | BAUSCH & LOMB INC. | E4222 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR |