MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUTURE 36"(90CM) 0 VIO; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP358T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 1/5/2023.Component code: (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested, the following was obtained: could you please clarify if the patient suffered from any signs or consequences due to the issue? please provide more details.No.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.Trade name - irgacare.Active ingredient(s)- triclosan.Dosage form - suture/solid/parenteral.Strength - 2360 g /m.
Event or Problem Description
It was reported that a patient underwent a wound closure procedure on (b)(6) 2022 and suture was used.It was reported that the suture broke when sewing in surgery.Changed another one to complete the surgery.There were no patient consequences reported.Additional information was requested.

• Brand Name: PDS PLUS SUTURE 36"(90CM) 0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; cuidad juarez 32604 ; MX 32604
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16108531
• Report Number: 2210968-2023-00120
• Device Sequence Number: 3199575
• Product Code: NEW
• UDI-Device Identifier: 10705031048171
• UDI-Public: 10705031048171
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K061037
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/05/2023

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: 09/30/2023
• Device Model Number: PDP358T
• Device Catalogue Number: PDP358T
• Device Lot Number: RLMLTZ
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Female