MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; MINOR PACK

Catalog Number	DYNJ47225B
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the white thread of the gauze unraveled inside the surgical wound during an umbilical hernia repair.Per report, the surgeon used his hand to manually pick-up and to successfully retrieve the white thread from the surgical wound.There was no reported impact to the patient, the staff, or the procedure being performed.General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.Due to the reported incident and in an abundance of caution, this is an mdr reportable event.The sample was returned for evaluation and the complaint was confirmed.A root cause could not be identified at this time.No additional information is available.If additional information becomes available, this report will be reopened and reevaluated.
Event or Problem Description
It was reported that the white thread of the gauze unraveled inside the surgical wound during an umbilical hernia repair.

• Common Device Name: MINOR PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7600985
• Report Number: 1423395-2018-00035
• Device Sequence Number: 19214850
• Product Code: FDE
• UDI-Device Identifier: 10889942554324
• UDI-Public: 10889942554324
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/14/2018

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?: Yes
• Operator of Device: Physician
• Device Catalogue Number: DYNJ47225B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/14/2018
• 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: Required Intervention
• Patient Age: 63 YR