MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK10-0 20 CS-B-6(2); SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number 9008G

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

Patient Problems Inflammation (1932); Pain (1994); Not Applicable (3189)

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.Additional information was requested, and the following was obtained: please request the following information: what was the date of the initial procedure? (b)(6) 2019 for c-section.What tissue layer was the ethilon suture used on? incision.What were the patient¿s symptoms? abdominal incision pain.The incision was examined as redness, swelling and heat pain.The incision debridement and drainage were performed, and the secretions were sent for test.What post op date did the patient experience symptoms of inflammation? (b)(6).What was the date of the debridement and drainage procedure? unk.Were any cultures performed? what were the results? yes, unk.What is the surgeon opinion as to contributing factors to the symptoms? maybe suture.Do you have any samples of the same lot for evaluation? no.What is the current condition of the patient? stable.

Event Description

It was reported that the patient underwent a c-section procedure on (b)(6) 2019 and the suture was used on incision.On (b)(6) 2019, the patient experienced abdominal incision pain and post-op inflammation with redness, swelling and heat pain.The incision debridement and drainage were performed and then patient's condition changed better.The secretions were sent for test.There are unknown culture results.The surgeon opines that maybe suture contributed to the symptoms.The patient is stable currently.

Manufacturer Narrative

Product complaint # (b)(4).Additional information was requested and the following was obtained: reviewed mre.Pcf created to bq: you reported date of procedure? (b)(6) 2019 for c-section per the lot review, the lot kkr487 expired in 2003.Can you clarify the lot number? no further information can be provided.

Manufacturer Narrative

Product complaint #: (b)(4).A manufacturing record evaluation was performed for the finished device batch kkr487, 9008g and no non-conformances were identified.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.You reported date of procedure as (b)(6) 2019 for c-section, per the lot review, the lot kkr487 expired in 2003.Can you clarify the lot number?.

• Brand Name: ETHILON BLK10-0 20 CS-B-6(2)
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8907197
• MDR Text Key: 154777392
• Report Number: 2210968-2019-85751
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2003
• Device Catalogue Number: 9008G
• Device Lot Number: KKR487
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR