MAUDE Adverse Event Report: ETHICON INC. STFX SYM PDS+ UNI VIO 9IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number	SXPP1A423
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); 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 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, weight, bmi at the time of index procedure what tissue was the suture used on? what was the condition of the tissue (ie normal or thin, calcified, fragile, diseased)? how was the stratafix suture placed? was the suture placed starting at the end(left and right side) or middle of the incision? was there any anomaly noted with the stratafix device prior to use? what date post op did the patient return with symptoms? was an additional procedure performed to remove the suture? what was the date of the second procedure? what was the indication for suture removal? can you describe the appearance of the suture during the second procedure? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the condition of the patient?.
Event or Problem Description
It was reported that the patient underwent a laparoscopic assisted hysterectomy on (b)(6) 2019 and barbed suture was used to close the vaginal cuff.The patient returned on an unknown date, with extreme pain.The doctor removed the suture from the patient.Patient current status is unknown.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 3/27/2020.Additional information: a2, a4.Additional information was requested and the following was obtained: the patient demographic info: age, weight, bmi at the time of index procedure.38 years old, 109kg on (b)(6)2019.What tissue was the suture used on? pelvic/vaginal area.What was the condition of the tissue (ie normal or thin, calcified, fragile, diseased)? normal.Was an additional procedure performed to remove the suture? yes.What was the date of the second procedure? (b)(6)2020.What was the indication for suture removal? causing pain and discomfort for patient and patient spouse.
Additional Manufacturer Narrative
(b)(4).Attempts have been 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.

• Brand Name: STFX SYM PDS+ UNI VIO 9IN 0 S/A CT-1
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9788593
• Report Number: 2210968-2020-01740
• Device Sequence Number: 687757
• Product Code: NEW
• UDI-Device Identifier: 10705031245365
• UDI-Public: 10705031245365
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: No Information
• Device Model Number: SXPP1A423
• Device Catalogue Number: SXPP1A423
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 03/20/2020
• Initial Report FDA Received Date: 03/04/2020
• Supplement Report FDA Received Date: 03/27/2020; 04/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 109