MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 3-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J423H
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.Any medical treatment provided? if yes, please provide medicine name, strength and dose.Was any surgical intervention performed specially re-suturing? explain.Was dehiscence noted? issue on which used? what is the procedure name? what is the event day and procedure date? what is the current condition of the patient?.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.The suture was not absorbed resulting in suture abscesses.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 8/21/2020.Additional information: d4, h4, h6.A manufacturing record evaluation was performed for the finished device lj2255, and no non-conformances were identified.Additional information was requested and the following was obtained: any medical treatment provided? if yes, please provide medicine name, strength and dose.No.Was any surgical intervention performed specially re-suturing? explain.Just removed the suture what is the current condition of the patient? patient is fine now.No product is available for return.The following information was requested but unavailable: was dehiscence noted? tissue on which used? what is the procedure name? what is the event day and procedure date?.

• Brand Name: VCL CT BRD UD 27IN 3-0 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: 10376246
• Report Number: 2210968-2020-05913
• Device Sequence Number: 2567206
• Product Code: GAM
• UDI-Device Identifier: 10705031039759
• UDI-Public: 10705031039759
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: 07/31/2022
• Device Model Number: J423H
• Device Catalogue Number: J423H
• Device Lot Number: LJ2255
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1