MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 36IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number	Z346H
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	Wound Dehiscence (1154); No Code Available (3191)
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 a later date a supplemental medwatch will be sent.Attempts have been 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, gender, weight, bmi at the time of index procedure.Date of index surgical procedure.The diagnosis and indication for the index surgical procedure? what tissue type and location of the suture placement? what tissue dehisced? 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 were current symptoms following the index surgical procedure? onset date? did the reported issue occur on bilateral breasts or one breast? please clarify what is meant by ¿suture didn¿t hold¿; i.E., did the suture break; were the knots untied? other relevant patient history/concomitant medications.Lot # if applicable, will product be returned, return date, tracking information what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient¿s current status?.
Event or Problem Description
It was reported that the patient underwent breast augmentation on an unknown date and suture was used.Following the procedure, the suture didn¿t hold, causing the implant to extrude.A different suture was used to repair the suture used during the initial procedure.Additional information has been requested.

• Brand Name: PDSII VIO 36IN 0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9806335
• Report Number: 2210968-2020-01829
• Device Sequence Number: 16296224
• Product Code: NEW
• UDI-Device Identifier: 10705031060661
• UDI-Public: 10705031060661
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: Z346H
• Device Catalogue Number: Z346H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 03/09/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention