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

Catalog Number	PDP370T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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.H6 component code: g07002 device not returned.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: please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure 27y/o female, 77.27 kg, bmi 30.1.Date and name of index surgical procedure? (b)(6) 2025, r ltcs.The diagnosis and indication for the index surgical procedure? previous ltcs.What was the initial approach for the index surgical procedure? (open, laparoscopic or other)? open.On what tissue was the suture used/location of suture placement? fascia.What tissue dehisced? fascia.What was the tissue condition (normal, thin, calcified, fragile, diseased)? how was the suture placed (interrupted or continuous)? continuous.How was the suture tied (square knot or multiple knots one end)? onset date/time of dehiscence? (# post op days) 2/11/25 at 1320.What symptoms did the patient experience following the index surgical procedure? bleeding from incision site.Onset date? 2/11/25.How was the dehiscence managed? surgical repair.It was stated that the patient ¿returned for a wound dehiscence¿.Yes, please provide further clarification and details on this statement.Fascial dehiscence after c/s.Please describe any surgical intervention required for the wound dehiscence including date and findings.Repair of fascial dehiscence.Please describe the appearance of the suture during the second procedure.Pds snapped in the midline of the incision, omentum extruded in the subcutaneous space.Is it known how the wound dehisced? suture popped.Did the suture pull out of the tissue? did the suture break? yes, if so, where was the break noted (termination, middle, end)? middle.Were there any precipitating patient stress factors for the sutures untying, breakage or pulling out of the tissue? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement and during any re-operation? no.Other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? stable.Surgeon¿s name? dr.(b)(6).
Event or Problem Description
It was reported that a patient underwent an ltcs on (b)(6) 2025 and suture was used.On the same day, (b)(6) 2025, the patient had bleeding from incision site.The suture snapped in the midline of the incision, omentum extruded in the subcutaneous space.Patient had a fascial dehiscence and underwent a repair of the fascial dehiscence.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (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.Corrected d3 manufacturer email.Corrected h6 type of investigation.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.

• 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; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 21664945
• Report Number: 2210968-2025-03054
• Device Sequence Number: 7614564
• Product Code: NEW
• UDI-Device Identifier: 10705031048195
• UDI-Public: (01)10705031048195(17)250630(10)THMAXQ
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: PDP370T
• Device Lot Number: THMAXQ
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/06/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 77 KG