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

Catalog Number	PDP333H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930); Rash (2033); Not Applicable (3189); No Code Available (3191)
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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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 are you currently feeling? if in your possession, may we have a copy of your operative report to review which layer of tissue the suture was used? does ethicon have your permission to contact your 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 your surgeon¿s name, contact information and sign release of medical information form attached.
Event or Problem Description
It was reported by the patient that she underwent a stump reconstruction procedure on (b)(6) 2018 and suture was used.It was reported that the patient experienced signs of staph infection within three days after discharge.Eleven days post procedure, an additional procedure was performed where the wound was drained, debridement and a drain was placed which was secured with "cloth like" sutures which caused no issues.The cause of the staph infection is unknown.The patient experienced six stitch abscesses, sutures not dissolving and poking through or erupting the incision.The patient experienced multiple infections and was treated with multiple antibiotics with no resolution.The patient experienced rash.The sutures were removed on (b)(6) 2018 and the incision was re-closed with staples.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: PDS+ VIO 27IN 2-0 S/A CT-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: 8153223
• Report Number: 2210968-2018-77686
• Device Sequence Number: 1770681
• Product Code: NEW
• UDI-Device Identifier: 10705031048065
• UDI-Public: 10705031048065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2018

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 Expiration Date: 02/29/2020
• Device Catalogue Number: PDP333H
• Device Lot Number: MCZ757
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 12/11/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention