MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SDS MN BREAST PACK

Device Problem Material Disintegration (1177)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that when the surgeon was using the lap sponge during a procedure there were fibers noted to be left behind in the wound.It was not reported if or how the fibers were removed from the patient.There was no report of any consequence or impact to the patient or procedure as a result of the reported incident.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No sample was returned for evaluation.Due to the reported incident and in abundance of caution, this is a reportable event.If additional relevant information becomes available this report will be reopened and reevaluated.

Event Description

It was reported that when the surgeon was using the lap sponge during a procedure there were fibers noted to be left behind in the wound.

• Type of Device: SDS MN BREAST PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11515126
• MDR Text Key: 241412156
• Report Number: 1423395-2021-00014
• Device Sequence Number: 1
• Product Code: FTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention