FDA Adverse Event
Malfunction
Summary report: N
VELOSORB 3-0 UD 30 CV-23
MDR report key: 3190514
·
Received June 21, 2013
Report
- Report Number
- 3006981798-2013-00003
- Event Type
- Malfunction
- Date Received
- June 21, 2013
- Date of Event
- April 29, 2013
- Report Date
- June 21, 2013
- Manufacturer
- RIVERPOINT MEDICAL, LLC
- Product Code
- GAM
- PMA / PMN Number
- K120556
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
NEEDLE DETACHED FROM SUTURE DURING THE EXTRACTION OF A MOLAR. A 2ND SUTURE WAS THEN USED. THE NEEDLE OF THE 2ND SUTURE WAS BENT DURING THE PROCEDURE. THERE WAS NO REPORTED PROBLEM WITH THE PT. NO BLEEDING OR TISSUE LOSS OR EXTENSION OF THE INCISION BY MORE THAN ONE INCH. THE PROCEDURE WAS NOT DELAYED BY MORE THAN 30 MINUTES. THE SUTURE NEEDLE DID NOT FALL INTO THE PT. THE PT'S HOSPITAL STAY WAS NOT EXTENDED DUE TO THE INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 282675 | VELOSORB 3-0 UD 30 CV-23 | STUTURE, ABSORBABLE, SYNTHETIC, PGA | GAM | RIVERPOINT MEDICAL, LLC | CV1215 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |