Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RIVERPOINT MEDICAL VELOSORB FAST; SUTURE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RIVERPOINT MEDICAL VELOSORB FAST; SUTURE Back to Search Results
Model Number CV-917
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/06/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
A review of the device history record was performed and all samples tested passed finished goods testing with no issues noted with the lot prior to release.Retained samples from the same lot were tested for finished goods testing, including needle attachment and tensile strength and all samples passed.
 
Event or Problem Description
According to the reporter, during a perineal suture after a delivery, at the end for the closure, both the needle and thread broke.The surgical time was extended by 1 hour and 30 minutes to look for the needle with radiography.".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VELOSORB FAST
Common Device Name
SUTURE
Manufacturer (Section D)
RIVERPOINT MEDICAL
825 ne 25th ave.
portland OR 97232
MDR Report Key11133195
Report Number3006981798-2020-00013
Device Sequence Number19865004
Product Code GAM
UDI-Device Identifier20884521151656
UDI-Public20884521151656
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K120556
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date05/31/2021
Device Model NumberCV-917
Device Lot Number18060507X
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/22/2020
Initial Report FDA Received Date01/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
-
-