MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 96IN 1 S/A XLH LP; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z881G
Health Effect - Clinical Codes	Wound Dehiscence (1154); Not Applicable (3189)
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.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.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.What was the name of the procedure? what was the date of the initial procedure? what tissue layer was the pds suture used on? what was the condition of the tissue (normal, diseased, weak)? how was the suture placed (interrupted or continuous technique)? what is meant by ¿wound dehiscence¿? what date did the patient present with symptoms of wound opening? was a second procedure performed to treat the dehiscence? what was the date (post op) for the second procedure? can you describe the appearance of the pds during second procedure? were the knots intact and the suture broken? was the suture intact and pulled away from the tissue? what are the patient age, gender, weight and medical history? do you have any suture samples of z881g lot lmz625 for evaluation? what is the current condition of the patient?.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date.Following the procedure, the patient experienced wound closure dehiscence.The patient was returned to the or for additional procedure.Additional information has been requested.

• Brand Name: PDSII VIO 96IN 1 S/A XLH LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7542947
• Report Number: 2210968-2018-73050
• Device Sequence Number: 13918908
• Product Code: NEW
• UDI-Device Identifier: 10705031061927
• UDI-Public: 10705031061927
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/01/2018

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: 10/31/2022
• Device Catalogue Number: Z881G
• Device Lot Number: LMZ625
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention