MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 4-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number W9950T

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

Patient Problems Wound Dehiscence (1154); Foreign Body Reaction (1868); Scar Tissue (2060)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The diagnosis and indication for the index surgical procedure? what were current symptoms following the index surgical procedure? onset date? other relevant patient history? on what tissue was the suture used? how the suture was initially tied? can you describe the appearance of the suture during second procedure? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).Device not returned.Related events captured via 2210968-2021-04748.

Event Description

It was reported that a patient underwent surgery of the intradermal nevi excision on the back on (b)(6) 2021 and suture was used.The patient experienced deep stitch reaction of hypertrophic scarring and wound dehiscence and was treated with secondary intention healing and reoperation including scar refashioning.It was reported that the patient's tissue was thin.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to fda: 06/15/2021.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.Additional information was requested and the following was obtained: diagnosis for suspected atypical nevi the index case caused the wound disruption, patient is generally well and not on any medications.Suture was used subcutaneous/dermal.Horizontal closure suture closure second time was continuous non locking (vicryl, not pds).Surgeon's etiology: pds reaction.Patient's current status is well healed.A manufacturing record evaluation was performed for the finished device lot number qemajr / w9950t14, and no non-conformances related to the reported complaint condition were identified.Related events captured via 2210968-2021-04748 and 2210968-2021-04749.

• Brand Name: PDSII CLR 18IN 4-0 S/A FS-2
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11842439
• MDR Text Key: 251208366
• Report Number: 2210968-2021-04749
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W9950T
• Device Lot Number: QEMAJR
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR