FDA Adverse Event
Malfunction
Summary report: N
POREX SURGICAL PRODUCTS
MDR report key: 408876
·
Received July 29, 2002
Report
- Report Number
- 408876
- Event Type
- Malfunction
- Date Received
- July 29, 2002
- Date of Event
- July 12, 2002
- Report Date
- July 29, 2002
- Manufacturer
- POREX SURGICAL INC
- Product Code
- MBS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT HAD JONES TUBE INSERTED INTO RIGHT EYE. ATTEMPTED WITH 18MM MEDPORE WRAPPED JONES TUBE; TUBE BROKE, ALL PIECES RECOVERED. ATTEMPTED WITH 20MM MEDPORE WRAPPED JONES TUBE, TUBE BROKE ALL PIECES RECOVERED. 3RD ATTEMPT WITH A SMALLER, PLAIN JONES TUBE SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POREX SURGICAL PRODUCTS | MEDPOR SURGICAL IMPLANT | MBS | POREX SURGICAL INC | * | 005490502 H |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Other |