FDA Adverse Event
Summary report: N
CRAWFORD LACRIMAL INTUBATION SET
MDR report key: 11325
·
Received February 1, 1994
Report
- Report Number
- MW4000120
- Date Received
- February 1, 1994
- Report Date
- August 28, 1992
- Manufacturer
- JEDMED INSTRUMENT CO.
- Product Code
- HMX
- Report Source
- Voluntary report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DURING ROUTINE NASAL LACRIMAL DUCT PROBING, NUMEROUS CRAWFORD TYPE LACRIMAL INTUBATION SETS FAILED. PROBING WAS PERFORMED WITH A SIZE 1 BROWMAN PROBE. THE CRAWFORD INTRODUCER COULD BE EASILY PASSED BUT WHEN AN ATTEMPT WAS MADE TO PULL THE 00 SIZE TUBE BACK THROUGH THE NASAL LACRIMAL DUCT IT WOULD BREAK. SIX SETS WERE USED AND EACH FLEXIBLE TUBING BROKE IN THE SAME MANNER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRAWFORD LACRIMAL INTUBATION SET | HMX | JEDMED INSTRUMENT CO. | F-05-01X5, 286876X1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |