MAUDE Adverse Event Report: ETHICON INC. MCRYL UD 18IN 3-0 S/A PS-2 PRM MP; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	Y497G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Local Reaction (2035); Not Applicable (3189)
Date of Event	12/29/2019
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.Additional information was requested and the following was obtained: on what tissue was the suture used? skin&subcutaneous.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? normal.What skin prep was used on the patient? hibclens.Were there any changes in skin prep? no change.How was the suture placed (interrupted or continuous)? both.What was used to close the skin 3-0 monocryl.Did only one breast experience the reaction/ dehiscence? if so, which side? right.Can you describe the amount (in cm) of dehiscence/ opening? 5cm.Was any medical intervention performed when patient returned 12/29/2019 with symptoms? yes.Was medical intervention performed? if yes, please describe.Total resection of the area and resutured can you describe the appearance of the monocryl suture during the second procedure on (b)(6) 2020? looked normal.Do you have any photos of the reaction for evaluation? no.Can you describe the appearance of the monocryl suture during procedure on 1/28/2020? absent.Other relevant patient history/concomitant medications the incision was paper thin after the reaction to sutures.This was two months following breast augmentation.What is the physician¿s opinion as to the etiology of or contributing factors to this event? probably improper sterilization of the product.What is the patient¿s current status? healed.The following information was requested but unavailable: the patient demographic info: weight, bmi at the time of index procedure note: event related to (b)(6) 2019 sent via mw 2210968-2020-01723.Event related to (b)(6) 2020 sent via this report.
Event or Problem Description
It was reported that the patient underwent breast augmentation and crescent nipple lift on (b)(6) 2019 and suture was used to close the incision.It was reported that the suture was used on the skin and subcutaneous tissue and placed interrupted and continuous.The patient returned on (b)(6) 2019 with darkness along the incision line, burning, pain and 5cm wound dehiscence on the right breast.The patient underwent total resection of the area and resuturing.The patient's tissue was reported as paper-thin.On (b)(6) 2020, the patient experienced dehiscence and underwent resuturing with nylon suture.It was reported that the appearance of the suture used on (b)(6) 2019 was normal.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Additional information: d4, h4, h6 a manufacturing record evaluation was performed for the finished device mk6851 batch number, and no non-conformances were identified.Note: event reported via mw 2210968-2020-01723, 2210968-2020-01770, 2210968-2020-01771.

• Brand Name: MCRYL UD 18IN 3-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9795565
• Report Number: 2210968-2020-01770
• Device Sequence Number: 11313781
• Product Code: GAN
• UDI-Device Identifier: 10705031059399
• UDI-Public: 10705031059399
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K964072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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 Expiration Date: 08/31/2023
• Device Model Number: Y497G
• Device Catalogue Number: Y497G
• Device Lot Number: MK6851
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 03/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention