MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI 18IN 4-0 SA PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B113

Device Problem Break (1069)

Patient Problem Pocket Erosion (2013)

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Component code: g07002 - device not returned.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.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: were there any alleged deficiencies noted with the device that could have contributed to the patient¿s post-operative complications as mentioned in the event description? not reported.Was there any medical or surgical intervention performed (product removed; re-operation; re-closure; drainage)? if so, please specify.No surgical or medical treatment was performed.Only the protruding part of the the suture was desected.Was dehiscence noted? no.What is the current condition of the patient? no problem.Are there photo available for visual analysis? no.What is the lot number? unk.Wound dehiscence did not occur.The protrusion of the suture was cut as a treatment, and it was the only treatment which was done.It was confirmed that there was no inflammation.Trade name - irgacare®, active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, and strength ¿ = 2360 g/m.

Event Description

It was reported that a patient underwent a c-section procedure on an unknown date and barbed suture was used.Post-op, it was reported that, 2 or 3 months after a cesarean section, in the ward/icu, the product protruded from the epidermis.The product was used for dermal suture.The event occurred at not around the loop part but at the middle of the suture.The suture was broken and the suture stump protruded.The surgeon said that he used to use 4-0pds, which specification is unknown, with continuous suture and the same event never happened.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: SFX SPI PDS+ UNI 18IN 4-0 SA PS-2 PRM MP
• Type of Device: SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16383450
• MDR Text Key: 309639937
• Report Number: 2210968-2023-01141
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031236295
• UDI-Public: 10705031236295
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K150670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SXPP1B113
• Device Catalogue Number: SXPP1B113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1