MAUDE Adverse Event Report: ETHICON INC. VCL CT VIO 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J397H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Impaired Healing (2378); Not Applicable (3189)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: age, weight, bmi at the time of index procedure.What tissue type and location of the suture placement? what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? how was the suture placed (interrupted or continuous)? how was the suture tied (square knot or multiple knots one end)? what tissue split? did the tissue dehisce? when did the issue occur? was there any additional medical or surgical intervention provided after the suture was removed? what was the appearance of the suture when it was removed? date suture was removed? other relevant patient history/concomitant medications.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient current status?.
Event or Problem Description
It was reported that the patient underwent episiotomy on (b)(6) 2018 and suture was used.Following the procedure, the patient¿s incision healing was bad, split, abnormal incision granulation.There was no swelling, no pus.The surgeon removed suture and did not re-suture.The patient underwent daily bath with potassium permanganate, one week after healing.Additional information has been requested.
Additional Manufacturer Narrative
Pc-(b)(4).Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure unk what tissue type and location of the suture placement? unk what was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? unk how was the suture placed (interrupted or continuous)? unk how was the suture tied (square knot or multiple knots one end)? unk what tissue split? did the tissue dehisce? unk when did the issue occur? unk was there any additional medical or surgical intervention provided after the suture was removed? daily bath with potassium permanganate what was the appearance of the suture when it was removed? date suture was removed? unk other relevant patient history/concomitant medications unk what is physician¿s opinion as to the etiology of or contributing factors to this event? maybe suture what is the patient current status? stable.

• Brand Name: VCL CT VIO 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7927811
• Report Number: 2210968-2018-76232
• Device Sequence Number: 19169124
• Product Code: GAM
• UDI-Device Identifier: 10705031039575
• UDI-Public: 10705031039575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: J397H
• Device Lot Number: MB2379
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/30/2018
• Initial Report FDA Received Date: 10/02/2018
• Supplement Report FDA Received Date: 11/01/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention