MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 4-0 S/A SH-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number VCP310H

Device Problems Expulsion (2933); Appropriate Term/Code Not Available (3191)

Patient Problem Impaired Healing (2378)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts to obtain the following information have been made and the following was obtained: was resuturing done? please refer to the event description, no further information can be provided.Were any medicine's prescribed? please refer to the event description, no further information can be provided.Device return status could not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent an c-section on an unknown date and suture was used.On (b)(6) 2019, 35 days after sewing, there was an incision spot exposed in cesarean section.The suture spitting from the incision.Dressing change was given and the suture was removed.Then the patient's condition improved.

• Brand Name: VCL+ VIO 27IN 4-0 S/A SH-1
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt D2285 1; GM D22851
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9272064
• MDR Text Key: 196262947
• Report Number: 2210968-2019-89438
• Device Sequence Number: 1
• Product Code: GAM
• UDI-Device Identifier: 10705031052178
• UDI-Public: 10705031052178
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K032420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: VCP310H
• Device Lot Number: MK8CJPS0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1