FDA Adverse Event
Malfunction
Summary report: N
HAVEL'S 5-0 PLAIN GUT WITH C3 NEEDLE
MDR report key: 313038
·
Received January 12, 2001
Report
- Report Number
- MW4002932
- Event Type
- Malfunction
- Date Received
- January 12, 2001
- Report Date
- December 13, 2000
- Manufacturer
- SURGICAL SPECIALTIES CORP.
- Product Code
- GAL
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- NO INFORMATION
Narratives
Description of Event or Problem · 1
COMPLAINANT REPORTS THAT THE FIRM IS EXPERIENCING NEEDLE CORROSION WITH THESE PARTICULAR TWO LOTS. ALL PRODUCT WAS RETURNED TO THE MFR FOR REPLACEMENT. ACCORDING TO THE REPORT, THE MFR DID CONFIRM THE NEEDLE CORROSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1646 | HAVEL'S 5-0 PLAIN GUT WITH C3 NEEDLE | 5-0 PLAIN GUT WITH C3 NEEDLE | GAL | SURGICAL SPECIALTIES CORP. | NI | MG003830/MC02540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO |