FDA Adverse Event
Malfunction
Summary report: N
RICHARD-ALLAN
MDR report key: 163725
·
Received April 6, 1998
Report
- Report Number
- MW1013591
- Event Type
- Malfunction
- Date Received
- April 6, 1998
- Date of Event
- March 9, 1998
- Report Date
- March 26, 1998
- Manufacturer
- RICHARD-ALLAN MEDICAL INDUSTRIES,INC.
- Product Code
- GAB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
FREE NEEDLE EYE BROKE OFF OF BODY OF NEEDLE WHILE SUTURING INCISION IN PT'S SHOULDER. X-RAY TAKEN; NO NEEDLE FOUND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RICHARD-ALLAN | SUTURE NEEDLE (MAYO 1/2 TAPER) | GAB | RICHARD-ALLAN MEDICAL INDUSTRIES,INC. | 216705 | 07 MAR 02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |