FDA Adverse Event
Injury
Summary report: N
CRAWFORD LACRIMAL INTUBATION SET
MDR report key: 251817
·
Received November 19, 1999
Report
- Report Number
- 251817
- Event Type
- Injury
- Date Received
- November 19, 1999
- Date of Event
- September 21, 1999
- Report Date
- October 14, 1999
- Manufacturer
- JEDMED INSTRUMENT CO.
- Product Code
- HNW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IN 1999 THE PT UNDERWENT UPPER AND LOWER PLASTIC REPAIR OF RIGHT-SIDED CANALICULI, NASAL LACRIMAL DUCT PROBING WITH INTUBATION, AND INFRACTURE OF THE MIDDLE TURBINATE. THREE ATTEMPTS WERE REQUIRED FOR CRAWFORD TUBE PLACEMENT, AS THE TUBES CONTINUED TO BREAK UPON PASSAGE. FINALLY, A TUBE WAS PASSED SUCCESSFULLY THROUGH THE CANALICULI. THE PT RETURNED TO SURGERY FOR THE SECOND STAGE OF THE PROCEDURE. AT THAT TIME, A PIECE OF THE LACRIMAL INTUBATION SET FROM THE PREVIOUS SURGERY WAS FOUND IN THE CANALICULI. THE PHYSICIAN REMOVED THE RETAINED PIECE OF TUBING AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CRAWFORD LACRIMAL INTUBATION SET | LACRIMAL INTUBATION SET | HNW | JEDMED INSTRUMENT CO. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Required Intervention |