MAUDE Adverse Event Report: ETHICON INC. STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT; SUTURE, SURGICAL, ABSORBABLE

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

Patient Problems Wound Dehiscence (1154); Adhesion(s) (1695); Fistula (1862); Obstruction/Occlusion (2422)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a hiatal hernorraphy procedure on an unknown date and a barbed suture was used for closure.Three weeks post-op, the patient experienced an abdominal wound dehiscence.Event was described as patient bent over while at a coffee shop and the abdominal incision completely dehisced.The patient ended up in the emergency room and was currently in icu following additional bowel resection and abdominal wash as bowel was contained in shopping bag upon arrival to hospital.The doctor mentioned that the attending surgeon described that the suture had captured a portion of the small bowl midway through lumen which fused it to the abdominal wall.A partial bowel obstruction was present along with fistula formation at base of incision.The surgeon did not place blame on the barbed suture but has requested that closure technique be reviewed with the residents.The surgeon believes the terminal bites which were thrown by resident to lock stitch were the cause of bowel being captured which ultimately led to the undesired outcome.Additional information was requested.

Manufacturer Narrative

(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Note: events reported in 2210968-2022-05910.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.

• Brand Name: STRATAFIX SYMMETRIC PDS UNKNOWN PRODUCT
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC. - JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15103738
• MDR Text Key: 296586138
• Report Number: 2210968-2022-05909
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention