MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAPAROTOMY UNIVERSAL PACK-LF

Catalog Number	DYNJ0977627F
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unknown procedure a white label from a towel fell off intraoperatively into a patient's abdominal cavity.It was not reported at what stage of the procedure the label fell off of the towel or details of the retrieval of the label.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 patient, product or incident details to the manufacturer.No sample has been received for evaluation.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.
Event or Problem Description
It was reported that during an unknown procedure a white label from a towel fell off intraoperatively into ta patient's abdominal cavity.

• Common Device Name: LAPAROTOMY UNIVERSAL PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9197705
• Report Number: 1423395-2019-00038
• Device Sequence Number: 18955348
• Product Code: LRO
• UDI-Device Identifier: 10889942551545
• UDI-Public: 10889942551545
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/16/2019

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: DYNJ0977627F
• Device Lot Number: 19FBO808
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/16/2019
• 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