MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 60IN 0 S/A TP-1 LP; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z991G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Not Applicable (3189)
Date of Event	07/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Attempts are being made to clarify 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, gender, 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)? product lot number? what tissue dehisced? how was the dehiscence managed? did the operating surgeon observe any suture deficiency or anomaly during abdominal dehiscence repair? what is physician¿s opinion as to the etiology of or contributing factors to this event (abdominal dehiscence)? other relevant patient history/concomitant medications? what is the patient¿s current status?".
Event or Problem Description
It was reported that the patient underwent an exploratory colon surgery on (b)(6) 2020 and the suture was used for abdominal closure.The patient returned with abdominal dehiscence on (b)(6) 2020 and required a repair.The revision surgery was performed on (b)(6) 2020.Additional information has been requested.

• Brand Name: PDSII VIO 60IN 0 S/A TP-1 LP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10311933
• Report Number: 2210968-2020-05496
• Device Sequence Number: 16797455
• Product Code: NEW
• UDI-Device Identifier: 10705031061996
• UDI-Public: 10705031061996
• Combination Product (Y/N): N
• 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): 07/10/2020

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 Model Number: Z991G
• Device Catalogue Number: Z991G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 07/22/2020
• 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