MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; MAJOR LAPAROTOMY PACK

Catalog Number	DYNJ59177A
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to facility on (b)(6) 2025 "a piece of hair was found inside of the basin that was from the pack (kit)".Per the facility "supplies were opened in a sterile fashion onto the or table and or table was set up, once procedure was started it was noted there was a piece of hair in the basin on the back table".Per the facility prophylactic antibiotics were given due to the hair being located.The sample was requested for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.
Event or Problem Description
According to facility on (b)(6) 2025 "a piece of hair was found inside of the basin that was from the pack (kit)".

• Common Device Name: MAJOR LAPAROTOMY PACK
• 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: 21890862
• Report Number: 1423395-2025-00036
• Device Sequence Number: 8146687
• Product Code: LRO
• UDI-Device Identifier: 10193489299496
• UDI-Public: 10193489299496
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/23/2025

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
• Device Catalogue Number: DYNJ59177A
• Device Lot Number: 24KLA891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 102 KG