FDA Adverse Event
Other
Summary report: N
HAVEL'S 5-0 PLAIN GUT WITH CC-77 NEEDLE
MDR report key: 306589
·
Received November 27, 2000
Report
- Report Number
- 2522801-2000-00002
- Event Type
- Other
- Date Received
- November 27, 2000
- Date of Event
- October 26, 2000
- Report Date
- November 27, 2000
- Manufacturer
- SURGICAL SPECIALTIES CORP.
- Product Code
- GAL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 10/26/00 THE DISTRIBUTOR ISSUED A VERBAL AND WRITTEN REPORT TO SURGICAL SPECIALTIES CORP. THE ORIGINAL REPORT OF COMPLAINT WAS REGISTERED TO THE DISTRIBUTOR BY AN END USER. THE END USER STATED THAT THERE WERE BLACK SPOTS ON THE NEEDLE. THERE WAS NO PT INCIDENT TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAVEL'S 5-0 PLAIN GUT WITH CC-77 NEEDLE | SUTURE AND NEEDLE | GAL | SURGICAL SPECIALTIES CORP. | A77C | MG02540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |