MAUDE Adverse Event Report: COLOPLAST A/S DIGITEX SUTR ABS PDO 2-0 W/NDL; ABSORBALE SUTURE

Model Number	5203102400
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/30/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, physician passed the suture through the ssl and upon placement physician didn't like the position of the suture and went to pull the suture out and the bullet (pellet) detached from the suture.At this point they confirmed that there was no bullet on the end of the suture.The bullet (pellet) was never found.The physician continued the case using 7 additional sutures and completed the surgery successfully.

• Brand Name: DIGITEX SUTR ABS PDO 2-0 W/NDL
• Common Device Name: ABSORBALE SUTURE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• MDR Report Key: 5591741
• Report Number: 2125050-2016-00047
• Device Sequence Number: 384062
• Product Code: NEW
• UDI-Device Identifier: 05708932504010
• UDI-Public: 05708932504010
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K120284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2016

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: Physician
• Device Expiration Date: 01/18/2018
• Device Model Number: 5203102400
• Device Catalogue Number: 5203102400
• Device Lot Number: 4642589
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2016
• Initial Report FDA Received Date: 04/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other