MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 36"(90CM) 1 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP959H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994); Not Applicable (3189)
Date of Event	01/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.A manufacturing record evaluation was performed for the finished device mh2346 number, and no non-conformances related to the reported complaint condition were identified.¿ additional information was requested and the following was obtained: what tissue type and location of the suture placement? ¿ the location is the fascia, following pfannenstiel incision.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased ¿ tissue's condition was well, to diabetes, no pus.Was there any precipitating stress factor for the sutures breakage?- no.Did the operating surgeon observe any suture deficiency or anomaly before or during the suture placement? - no.Other relevant patient history/concomitant medications - no.What is physician¿s opinion as to the etiology of or contributing factors to this event? ¿ there are no contributing factors.
Event or Problem Description
It was reported that a patient underwent a c-section procedure on (b)(6) 2019 and suture was used.The suture was used on the fascia with a continuous suturing technique.The patient experienced pain on (b)(6) 2019 and examination showed a full eventration of the fascia layer with bowels popping out.A re-laparotomy was performed on (b)(6) 2019 and the surgeon noted that the suture was torn in the middle, while the knots were intact.The fascia was re-sutured with a different suture with a middle knot.It was reported that the patient did not cough during the post-section recovery.The patient¿s condition is reported as well and discharged (b)(6) 2019.Additional information has been requested.

• Brand Name: VICRYL PLUS SUTURE 36"(90CM) 1 UND
• 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: 8312728
• Report Number: 2210968-2019-78731
• Device Sequence Number: 183478
• Product Code: GAM
• UDI-Device Identifier: 10705031056237
• UDI-Public: 10705031056237
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2019

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: 06/30/2023
• Device Catalogue Number: VCP959H
• Device Lot Number: MH2346
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 02/06/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 36 YR
• Patient Weight: 75