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

Model Number Y497G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Cellulitis (1768); Skin Irritation (2076); Not Applicable (3189); No Code Available (3191)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device mk6851 batch number, and no non-conformances were identified.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.The patient demographic info: age, gender, weight, bmi at the time of index 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 was the appearance of the suture on (b)(6) 2020? please provide additional information regarding ¿incision was closed¿, i.E., was resuturing performed? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra-op? were cultures performed? results? other relevant patient history/concomitant medications? 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 Description

It was reported that a patient underwent a mastoplexy, exchange of implants and partial capsulectomy of right breast on (b)(6) 2019 and suture was used to close the incision.On (b)(6) 2020, the patient returned with stitch irritation, skin cellulitis, wound dehiscence and a small drop of prolescence drainage from the wound site.The doctor cleaned the incision area, closed the incision and prescribed levaquin 500 mg for seven days.The patient was scheduled to return in a week for a follow-up.Additional information has been requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 3/19/2020.Additional information: a2, a3, a4.Additional h6 patient code: 1690.H6 patient codes: 2076, 1768, 1154, 3189 - surgical intervention, 3191 - wound secretion, 1690.Additional information was requested and the following was obtained: the patient demographic info: age 58, gender female, weight 139, bmi ?at the time of index procedure.The diagnosis and indication for the index surgical procedure? patient had ptosis of the breasts, had a breast lift with exchange of implants and capsulectomies.What tissue type and location of the suture placement? skin & subcutaneous tissue just under areolar.What tissue dehisced? yes.What was the tissue condition, i.E., normal or thin, calcified, fragile, diseased? necrotic and some purulence.How was the suture placed (interrupted or continuous)? square knot.How was the suture tied (square knot or multiple knots one end)? square knot.What was the appearance of the suture on 2/4/2020? not present due to infection.Please provide additional information regarding ¿incision was closed¿, i.E., was resuturing performed? incision open, purulence drained and patient placed on antibiotics were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no.Did the patient receive any prophylactic antibiotics pre-, intra-op? were cultures performed? results? yes, staphaureus.What is physician¿s opinion as to the etiology of or contributing factors to this event cellulitis and suture abcess.What is the patient¿s current status? healing secondarily.The following information was requested but unavailable: other relevant patient history/concomitant medications.If applicable, will product be returned, return date, tracking information.

• Brand Name: MCRYL UD 18IN 3-0 S/A PS-2 PRM MP
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9787813
• MDR Text Key: 186744425
• Report Number: 2210968-2020-01732
• Device Sequence Number: 1
• Product Code: GAN
• UDI-Device Identifier: 10705031059399
• UDI-Public: 10705031059399
• Combination Product (y/n): N
• PMA/PMN Number: K964072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 63