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: TELEFLEX MEDICAL TEV GN BR 0 TC-43/HR26 2N 36"; SUTURE, NONABSORBABLE, SYNTHE
  • 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
 

TELEFLEX MEDICAL TEV GN BR 0 TC-43/HR26 2N 36"; SUTURE, NONABSORBABLE, SYNTHE Back to Search Results
Model Number IPN000859
Medical Device Problem Code Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/18/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).No issues or discrepancies were found in the device history record of product code 833-114 / batch 74f1902783 that can be related to the failure mode reported.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event or Problem Description
During sacrospinous fixation the bullet at the tip of the suture got stuck in the capio slim while pushing the handle of the capio.This event happened several times and finally, she had to use another capio slim to solve the problem.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TEV GN BR 0 TC-43/HR26 2N 36"
Common Device Name
SUTURE, NONABSORBABLE, SYNTHE
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key12225498
Report Number3004365956-2021-00245
Device Sequence Number4486763
Product Code GAT
UDI-Device Identifier14026704603876
UDI-Public14026704603876
Combination Product (Y/N)N
Initial Reporter StateMA
Initial Reporter CountryUS
PMA/510(K) Number
K021019
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date06/23/2024
Device Model NumberIPN000859
Device Catalogue Number833-114
Device Lot Number74F1902783
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date07/26/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-