MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 27IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J397H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Inflammation (1932)
Date of Event	09/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device (b)(4), and no non-conformances were identified.Attempts are being made to retrieve the device.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.
Event or Problem Description
It was reported that the patient underwent lateral episiotomy surgery on (b)(6) 2019 and suture was used.On (b)(6) 2019, the suture broke and incision split after surgery, including muscle layer and skin.The wound has inflammation, white secretion and no erythema.The patient was treated with removal of the suture and a sitting bath with potassium permanganate twice a day.After seven days, the patient condition changed to better.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #: (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: were both products, j345h (1) and j397h(1) used on the patient during episiotomy? yes, j345h and j397h were used in lateral perineal resection.J345h was used to suture muscular mucosa, and j397h was used for sewing skin.Which suture was found broken and removed during post-op period? both sutures were broken and removed.Were any medicines prescribed e.G.Steroids/ antibiotics? if yes, provide name, strength and dose? no steroids or antibiotics were used.Was there any surgical intervention required? re-suturing done? unk.Additional device reported in mw 2210968-2019-90528.

• Brand Name: VCL CT BRD VIO 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9411014
• Report Number: 2210968-2019-90529
• Device Sequence Number: 2934524
• Product Code: GAM
• UDI-Device Identifier: 10705031039575
• UDI-Public: 10705031039575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: J397H
• Device Lot Number: MJ7705
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 12/04/2019
• Supplement Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1