MAUDE Adverse Event Report: ETHICON INC. PDS+ CLR 27IN 4-0 S/A FS-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP422H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Fatigue (1849); Fever (1858); Unspecified Infection (1930); Pain (1994); Not Applicable (3189)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 obtained: [surgeon¿s comment] infectious bacteria are mrse.The infection is not caused by the product but is considered to be due to the procedure or communication with the patient.As of (b)(6) 2019, the patient¿s condition is stable (the patient is not hospitalized originally).The following information was requested, but unavailable: no further information will be provided.Lot # unknown.What date did the patient present with symptoms (# post op days)? any suture absorption issues (fast or slow)? was any medical/surgical intervention done on patient post-op? was any re-operation/re-suturing/ revision surgery done on patient post-op after initial procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? no further information is available.Does the surgeon believe the event is due to suture deficiency? the surgeon initially said ""there is a possibility that the suture was the source of the infection"", but when the sales-rep confirmed the situation again, the surgeon said ""the infection is not caused by the product but is considered to be due to the procedure or communication with the patient"".No further information will be provided.
Event or Problem Description
It was reported that the patient underwent cv port fixation procedure on (b)(6) 2018 and suture was used.The suture was used on dermal layer for wound of the upper right arm.A catheter was placed under the dermis.On (b)(6) 2019 the patient experienced fatigue, fever, pain and reddening at the cv port site.On (b)(6) 2019 the patient was evaluated at the hospital and incision site with pus adhesion.The surgeon opined that there was possibility of catheter infection.Chest xray confirmed that the port system was not damaged.An additional procedure was performed, and the suture and catheter were removed fluoroscopically.Debridement was performed for the reddening on the wound edge and the wound edge was closed with a different suture type.The patient condition is reported as stable.The surgeon opined that the infection is not caused by the product but is considered to be due to the procedure or communication with the patient.Additional information has been requested.

• Brand Name: PDS+ CLR 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8612193
• Report Number: 2210968-2019-81405
• Device Sequence Number: 14071588
• Product Code: NEW
• UDI-Device Identifier: 10705031048263
• UDI-Public: 10705031048263
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2019

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 Catalogue Number: PDP422H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2019
• Initial Report FDA Received Date: 05/15/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 48 YR
• Patient Weight: 54