MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Catalog Number SXPP1A401

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

Patient Problems Inflammation (1932); Scar Tissue (2060); Reaction (2414); No Code Available (3191)

Event Date 07/11/2019

Event Type  Injury  

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: the patient demographic info: age, weight, bmi at the time of index procedure.The patient¿s initials are (b)(6).Female.Were cultures performed? results? no further information is available.Did the patient receive any prophylactic antibiotics pre- or intra-op? no further information is available.Other relevant patient history/concomitant medications.No further information is available.What is physician¿s opinion as to the etiology of or contributing factors to this event? at the time of emergency cesarean section, it was in the condition of chorionic amniotic inflammation, and the infection risk was high.Does the surgeon believe there was any deficiency with the ethicon device used in this procedure that caused and/or contributed to the post-operative complications? the surgeon commented that suture protrusion from the wound site by surgical site infection is occasionally occurs, and there is a high possibility that there is no causal relationship with the product.What is the patient¿s current status? the patient visits the hospital regularly.No further information will be provided.Did both the stratafix and the pds suture extrude from the wound site? only stratafix extruded.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.Was there any alleged deficiency related to the pds suture that caused and/or contributed to the post-operative complications? note: event related to pds suture reported via medwatch 2210968-2019-85977.

Event Description

It was reported that the patient underwent caesarean section on (b)(6) 2019 and barbed suture was used on the fascia by continuous suturing when closing the wound.Two months or more post-operatively, the patient felt stiffness at the wound site.On (b)(6) 2019, when the patient visited the hospital, it was found that inflammation reaction occurred on the wound site.There was drainage from the stiff site.The barbed suture that was used for the fascia had protruded about 1 cm from the wound site.The wound site is the lower end 3 cm of the lower abdominal midline incision.The patient experienced light scarring.There was a 1 mm hole and slight redness at the center of it.The patient¿s wound was treated as an outpatient and the condition is recovering.Gentamicin and drenison tape were prescribed from another facility, shower washing at home and gentamicin application treatment.It was reported that depending on the condition, plastic surgery consultation will be considered.The surgeon opined that suture protrusion from the wound site by surgical site infection occasionally occurs, and there is a high possibility that there is no causal relationship with the product.It was reported that a contributing factor at the time of emergency cesarean section is condition of chorionic amniotic inflammation, and the infection risk was high.The patient visits the hospital regularly.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A CT-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez 32604 ; MX 32604
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8920171
• MDR Text Key: 155183419
• Report Number: 2210968-2019-85976
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031219342
• UDI-Public: 10705031219342
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: SXPP1A401
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention