MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; NORTH MINOR PACK-LF

Catalog Number	DYNJ0166780R
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility during a procedure an 18x18 lap sponge 'fell apart and had to be removed from the wound during surgery'.No additional information is available.
Additional Manufacturer Narrative
According to the facility during a procedure an 18x18 lap sponge 'fell apart and had to be removed from the wound during surgery'.No additional information is available as the facility was unable to provide any further details.The sample is not available and is unable to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: NORTH MINOR PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13891768
• Report Number: 1423395-2022-00009
• Device Sequence Number: 16589178
• Product Code: FDE
• UDI-Device Identifier: 10195327021559
• UDI-Public: 10195327021559
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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: Health Professional
• Device Catalogue Number: DYNJ0166780R
• Device Lot Number: 21JMF304
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown