MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 18IN 6-0 S/A P-1 PRM; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J489G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
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.The following information was requested, but unavailable: could you please confirm the lot number? lot hm595 is not being recognized by the system.No further information is available.How was the procedure completed? no further information is available.No further information will be provided.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.Note: events reported via: (b)(4).
Event or Problem Description
It was reported that a patient underwent a cosmetic surgery on (b)(6) 2021 and suture was used.During the surgery, during interrupted suturing on the dermis, suture breakage occurred with 4 sutures in a row.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: VCL CT BRD UD 18IN 6-0 S/A P-1 PRM
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11608111
• Report Number: 2210968-2021-02985
• Device Sequence Number: 11816155
• Product Code: GAM
• UDI-Device Identifier: 10705031040427
• UDI-Public: 10705031040427
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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 Model Number: J489G
• Device Catalogue Number: J489G
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1