MAUDE Adverse Event Report: ETHICON INC. PDS+ CLR 18IN 6-0 S/A P-1 PRM; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP489G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device mlz320 number, and no non-conformances were identified.
Event or Problem Description
It was reported that the patient underwent a ptosis procedure on (b)(6) 2019 and suture was used.The suture broke during interrupted suturing on the palpebral muscle layer.There were no adverse consequences to the patient.

• Brand Name: PDS+ CLR 18IN 6-0 S/A P-1 PRM
• 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: 8384523
• Report Number: 2210968-2019-79205
• Device Sequence Number: 16248203
• Product Code: NEW
• UDI-Device Identifier: 10705031048393
• UDI-Public: 10705031048393
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: PDP489G
• Device Lot Number: MLZ320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/02/2019
• Patient Sequence Number: 1