MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN USP1 S/A CT-1; SUTURE, SURGICAL, ABSORBABLE

Model Number SXPP1A404

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

Patient Problems Bacterial Infection (1735); Erythema (1840); Inflammation (1932); Swelling/ Edema (4577)

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

(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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Adverse events ( two vicryl sutures and one stratafix) were submitted via 2210968-2020-09579, and 2210968-2020-09582.

Event Description

It was reported that the patient underwent a prosthesis replacement surgery on (b)(6) 2020 and the barbed suture was used continuous on the muscle layer.The length of the surgical wound was 10 cm.Epidermis was closed with a skin stapler.On (b)(6) 2020, the surgical wound got swollen and became red, and inflammation occurred under the skin.On (b)(6) 2020, treatments such as reopening the wound and debridement were performed.Re-incision of 15 cm length was performed.The barbed suture was removed.The wound cleaning with cleaning solvent including vancomycin was performed.Then, the surgical wound was closed with nylon suture.It was reported that infection due to the implant has not occurred.Crp level did not increase.Cultivation was performed for the tissue of the surgical site and the suture which was taken during debridement.The patient has been hospitalized and is being monitored.It was also reported that there was no abscess created or observed.As a result of cultivation, mrse was detected.Clindamycin has been administered by intravenous drip.The doctor commented that the suture was not the cause because mrse was detected.

Manufacturer Narrative

Date sent to the fda: 12/04/2020.A manufacturing record evaluation was performed for the finished device batch, and no non-conformances were identified this report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN USP1 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
• MDR Report Key: 10946604
• MDR Text Key: 219545217
• Report Number: 2210968-2020-09584
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031227699
• UDI-Public: 10705031227699
• Combination Product (y/n): Y
• PMA/PMN Number: K113004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: SXPP1A404
• Device Catalogue Number: SXPP1A404
• Device Lot Number: QAMQLA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 65