MAUDE Adverse Event Report: ETHICON INC. PDS PLUS CLR 18IN 4-0 S/A PS-2 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP496G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Pain (1994); Local Reaction (2035)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.How long after the procedure did the reaction begin? what kind of symptoms is your friend experiencing? is your friend able to provide a copy of their operative report? does ethicon have your permission to contact their surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide the patient¿s name, surgeon¿s name, surgeon¿s contact information and sign release of medical information form attached.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).Related events captured via 2210968-2021-05956, 2210968-2021-05957, 2210968-2021-05958.
Event or Problem Description
It was reported that a patient underwent a mastectomy procedure on an unknown date in 2020 and suture was used.It was reported by a friend that the patient experienced a reaction likely due to the suture.The patient has been back to the hospital twice since the procedure to have the wound cleaned out and re-sutured due to severe infection.The patient is currently stable and seems to be improving.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 07/12/2021.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: h6.Additional information was requested and the following was obtained: how long after the procedure did the reaction begin? redness emerged about a week after operation.What kind of symptoms is your friend experiencing? pain increased after the procedure.Mobility was impacted negative.Patient could not raise arms.Redness occurred near stiches is your friend able to provide a copy of their operative report? yes, if needed does ethicon have your permission to contact their surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide the patient¿s name, surgeon¿s name, surgeon¿s contact information and sign release of medical information form attached.Could be provided if necessary.Related events captured via 2210968-2021-05956, 2210968-2021-05957, 2210968-2021-05958 and 2210968-2021-05959.

• Brand Name: PDS PLUS CLR 18IN 4-0 S/A PS-2 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12095580
• Report Number: 2210968-2021-05959
• Device Sequence Number: 4765780
• Product Code: NEW
• UDI-Device Identifier: 10705031048430
• UDI-Public: 10705031048430
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: PDP496G
• Device Catalogue Number: PDP496G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/14/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/12/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention