MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 27IN 3-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z398H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Abscess (1690); Purulent Discharge (1812)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an animal underwent a mass removal veterinary procedure in (b)(6) 2024 and suture was used.Post-op, it was reported by a customer from pismo beach veterinary clinic, that a patient (dog) had a reaction to the suture.They did a mass removal in (b)(6) 2024, and used the suture for that.They said that abscess appeared at surgical site, they cultured it and used antibiotics.They had to do another surgery to remove the tissue around the suture, and there was still suture in there along with puss like substance.On (b)(6) 2024 additional information was received and stated that tissue was thickened and fibrous with multiple draining areas, and mulitple small pieces of clear suture that looked like fishing line.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.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 via: customer replied to email feed on (b)(6) with answers and images were attached.Can you identify the lot number of the product that was used? lot no.Tlmbkc was there any deficiency with the device? no, we are thinking it was a reaction to the suture what was the appearance of the suture after the reoperation on the animal? please explain.Tissue was thickened and fibrous with multiple draining areas, and mulitple small pieces of clear suture that looked like fishing line please provide the source or name and title of the external person providing answers to follow-up (external person submitting answers to sales rep) (b)(6), technical supervisor (b)(6).D4: udi: the manufacture and expiration dates are currently not available.Therefore, the full udi is currently not available.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 inc, or its employees, that the report constitutes an admission that the product, ethicon inc, 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.

• Brand Name: PDSII VIO 27IN 3-0 S/A FS-2
• 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: 20318012
• Report Number: 2210968-2024-10342
• Device Sequence Number: 7660137
• Product Code: NEW
• UDI-Device Identifier: 10705031060845
• UDI-Public: (01)10705031060845(17)280930(10)TLMBKC
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2024

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 Catalogue Number: Z398H
• Device Lot Number: TLMBKC
• 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: 08/27/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2023
• 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
• Patient Sex: Unknown