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

Model Number	PDP422H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 following information was requested, but unavailable: what tissue/location was suturing when pull off occurred? no further information is available.Was the needle piece removed from the patient during the same procedure? no further information is available.Were there any unexpected outcomes or complications as a result of this suture needle pull off event? no further information is available.Lot number? no further information is available.How was case completed? no further information is available.Event date? no further information is available.Procedure date= no further information is available.No further information will be provided.Trade name - irgacare® ,active ingredient(s) ¿ triclosan, dosage form ¿ suture/solid/parenteral, strength = 2360 g/m.
Event or Problem Description
It was reported that a patient underwent an unknown ob-gyn procedure on an unknown date and suture was used.During the procedure, the needle detached from the suture.No adverse patient consequences were reported.Additional information was requested.

• Brand Name: PDS+ CLR 27IN 4-0 S/A FS-2
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13281489
• Report Number: 2210968-2022-00460
• Device Sequence Number: 11999630
• Product Code: NEW
• UDI-Device Identifier: 10705031048263
• UDI-Public: 10705031048263
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/18/2022

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 Model Number: PDP422H
• Device Catalogue Number: PDP422H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown