MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SPONGE,LAP,18X18,DLX,XR,ST,10/PK,20PK/C

Catalog Number	MDS251518LFT
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an unidentified procedure, the loop pulled away from the lap sponge and the lap sponge was retained in the surgical site.After multiple good-faith attempts, the facility contact was unable or unwilling to provide additional patient, product, or procedural information related to the reported incident.It is unknown how the lap sponge was originally being used during the procedure.It is unknown if the reported loop separation occurred during first use of the lap sponge.It is unknown if the retained lap sponge was identified during or after the procedure.The method used to retrieve the retained lap sponge from the surgical site was not identified.It is unknown if the patient required additional medical intervention or follow-up care related to this incident.No additional details related to this incident were reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause could not be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an unidentified procedure, the loop pulled away from the lap sponge and the lap sponge was retained in the surgical site.

• Common Device Name: SPONGE,LAP,18X18,DLX,XR,ST,10/PK,20PK/C
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8073835
• Report Number: 1417592-2018-00108
• Device Sequence Number: 215081
• Product Code: GDY
• UDI-Device Identifier: 10884389159774
• UDI-Public: 10884389159774
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/15/2018

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: Health Professional
• Device Catalogue Number: MDS251518LFT
• Device Lot Number: 84317070128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2018
• Initial Report FDA Received Date: 11/15/2018
• 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: Other; Required Intervention