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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fluid Discharge (2686)

Event Date 08/05/2022

Event Type  Injury  

Event Description

It was reported that a patient underwent a lumbar surgery and a barbed suture was used with a continuous method on the dermis.About 2 days after the procedure when in the ward/icu, exudate from the wound occurred.The wound was covered by 3m tape and dressing, and re-suture was done in the doctor room.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 9/27/2022.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.¿ trade name - irgacare® ¿ active ingredient(s) ¿ triclosan ¿ dosage form ¿ suture/solid/parenteral ¿ strength ¿ = 2360 ¿g/m 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: was there any medical or surgical intervention performed (product removed; re-operation; re-closure; drainage)? if so, please specify.No surgical intervention.Covered by 3m tape and dressing, and re-suture in doctor room.Could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.No.What is the lot number? no.No further information will be provided 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.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? what was the initial approach for the index surgical procedure? (open, laparoscopic or other)? what was the tissue condition (normal, thin, calcified, fragile, diseased)? was the fixation loop secured to tissue at the initiation of suture use during the index procedure? was at least one reverse stitch performed prior to closure? what is the alleged deficiency of the suture? why was re-suturing required? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? note: event reported in 2210968-2022-07958, and 2210968-2022-07959.

Manufacturer Narrative

(b)(4).Date sent to the fda: 10/20/2022.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.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=>unknown.Date and name of index surgical procedure?=>lumbar operation.Date is unknown.The diagnosis and indication for the index surgical procedure? =>unknown what was the initial approach for the index surgical procedure? (open, laparoscopic or other)?=>unknown.What was the tissue condition (normal, thin, calcified, fragile, diseased)?=>unknown.Was the fixation loop secured to tissue at the initiation of suture use during the index procedure?=>unknown was at least one reverse stitch performed prior to closure?=>unknown what is the alleged deficiency of the suture?=>unknown.Why was re-suturing required?=>no.Removal of the suture in doctors office, medical tape and dressing was performed.Did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation?=>not reported.What is the physician¿s opinion as to the etiology of or contributing factors to this event?=>the surgeon said he didn't change the procedure and fell strenge to confirmed bleed.What is the patient's current status?=>no problem.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.Please confirm: was re-suturing performed in the doctor¿s office? what is meant by the statement ¿the surgeon said he didn't change the procedure and fell strenge to confirmed bleed.¿ please clarify and provide further details.

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.Additional information was requested, and the following was obtained: please confirm: was re-suturing performed in the doctor¿s office? yes.What is meant by the statement ¿the surgeon said he didn't change the procedure and fell strenge to confirmed bleed.¿ he didn't change the method of suture but the bleeding occured, so he felt strenge in this case.Please clarify and provide further details.No further information is available.No further information will be provided.

• 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 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15498307
• MDR Text Key: 300705436
• Report Number: 2210968-2022-07957
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 10/31/2022
• 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
• Patient Outcome(s): Required Intervention