MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUT 18IN(45CM) 4-0 CLR; SUTURE, SURGICAL, ABSORBABLE

Model Number PDP507

Device Problem Component Incompatible (1108)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts have been made to retrieve the device.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.

Event Description

It was reported that a patient underwent an unknown plastic surgery on (b)(6) 2018 and suture was used.During the procedure, it was noted that the suture looked thicker than usual.There were no adverse consequences to the patient.No additional information was provided.

Manufacturer Narrative

(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional summary: it was reported appearance - cosmetic or color ¿ suture and assembly - incorrect component.A top foil and a dispensed needle/suture combination were returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.The suture was examined along of strand and no defects or unusual color were observed on the suture.Also, a functional test was performed on the sample using and the diameter met the requirements.No incorrect component was observed.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, no appearance cosmetic or color ¿ suture or assembly - incorrect component were found.

• Brand Name: PDS PLUS SUT 18IN(45CM) 4-0 CLR
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125; col salvacar; ciudad juarez ; MX
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7818289
• MDR Text Key: 118405522
• Report Number: 2210968-2018-75436
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031048478
• UDI-Public: 10705031048478
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: PDP507
• Device Catalogue Number: PDP507G
• Device Lot Number: MGM679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1