MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN V-LOC 180; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number VLOCL0814

Device Problem Material Erosion (1214)

Patient Problems Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, 12 days following an inguinal hernia repair procedure, the patient underwent an emergency operation due to blockage.The peritoneal stitches from the suture used on the original procedure had internalized in the small intestine creating a volvulus and blockage.

• Brand Name: V-LOC 180
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer (Section G): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7864715
• MDR Text Key: 119832553
• Report Number: 1219930-2018-04956
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 20884521131320
• UDI-Public: 20884521131320
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091087
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: VLOCL0814
• Device Catalogue Number: VLOCL0814
• Device Lot Number: A7F0586VX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Date Device Manufactured: 06/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention