MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDS+ UNI VIO 6IN 2-0 S/A SH; SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE

Model Number SXPP1B415

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Peritonitis (2252)

Event Date 04/05/2022

Event Type  Injury  

Event Description

It was reported during a clinical trial that a patient underwent a sleeve gastrectomy on (b)(6) 2022 and barbed suture was used for staple line reinforcement.The patient developed local peritonitis upper abdomen with suture insufficiency, renewed operation with lavage and abscess on the spleen.Adverse event term: local peritonitis upper abdomen with suture insufficiency start date: (b)(6) 2022.Permanent impairment of a body structure or a body function: no.Required in-patient hospitalization or prolongation of existing hospitalization: yes.Admission date: blank.Resulted in medical or surgical intervention: yes.Relationship to study device: possible.Relationship to primary study procedure: possible.Intervention/treatment: diagnostic intervention: yes.Aspiration/drainage: yes.Culture taken: yes.Injected medication: yes.Observation: yes.Outcome: recovering/resolving.According to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: no.Adverse event term: renewed operation with lavage start date: (b)(6) 2022.Permanent impairment of a body structure or a body function: no.Required in-patient hospitalization or prolongation of existing hospitalization: no.Resulted in medical or surgical intervention: yes.Relationship to study device: possible.Relationship to primary study procedure: possible.Intervention/treatment: diagnostic intervention: yes.Thermal treatments for pain management: yes.Outcome: recovering/resolving.According to the protocol and instructions for use, in the opinion of the investigator, is the adverse event expected/anticipated: yes.

Manufacturer Narrative

Product complaint # (b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 g/m all others.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: the patient has a re-operation and found to have an abscess on the spleen, not related to the suture.

Manufacturer Narrative

(b)(4).Date sent to the fda: 6/1/2022.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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Lot qkbmd is an invalid lot.What is the correct lot number? (b)(4).Corrected information: d4 - lot number -unknown.

Manufacturer Narrative

Product complaint #: (b)(4).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.Additional informaiton: h4.Additional informaiton: d4 expiration date, h6 type of investigation.Device history lot: a manufacturing record evaluation was performed for the finished device batch qkbdmd, sxpp1b41513 and no non-conformances were identified.Mfg.Date - 9/23/2020.Exp.Date - 8/31/2022 corrected information: d4 lot #.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: 9/13/2022 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.Updated: adverse event term -> renewed operation with lavage - peritoneal lavage.

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.Updated: admission date: (b)(6) 2022.Discharge date: (b)(6) 2022.

• Brand Name: SFX SPI PDS+ UNI VIO 6IN 2-0 S/A SH
• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14310990
• MDR Text Key: 290945498
• Report Number: 2210968-2022-03444
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031235885
• UDI-Public: 10705031235885
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K150670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: SXPP1B415
• Device Catalogue Number: SXPP1B415
• Device Lot Number: QKBDMD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female