MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SPONGE,DISSECTOR,ROUND CHERRY,XR,ST,5/PK

Catalog Number	MDS71757
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility "the product was loose and fraying leaving loose particles they had to retrieve during use".Per the facility the patient was not injured as they immediately removed the item upon noticing it unraveling.Per the facility the product was inspected prior to use and it appeared "normal and intact".No additional information is available at this time.The sample was requested for evaluation.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 the facility "the product was loose and fraying leaving loose particles they had to retrieve during use".

• Common Device Name: SPONGE,DISSECTOR,ROUND CHERRY,XR,ST,5/PK
• 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: 17225229
• Report Number: 1417592-2023-00269
• Device Sequence Number: 12535335
• Product Code: GDY
• UDI-Device Identifier: 10884389106297
• UDI-Public: 10884389106297
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 06/29/2023

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: MDS71757
• Device Lot Number: 6052212051
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 06/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown