MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SPONGE,NEURO,0.5"X3",XR,STRL,LF,10/PK

Catalog Number	NEUROSPNG09
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	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on 06/10/2024, "during mma (maxillomandibular advancement) procedure, 1/2" by 3" patty string ripped out of patty and piece of patty broke off with it.Md immediately noticed when it happened and was able to safely remove all pieces of the patty and string.There was no physical harm, no monitoring/intervention was required for patient and the procedure was completed".A sample is not available 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 customer on 06/10/2024, "during mma (maxillomandibular advancement) procedure, 1/2" by 3" patty string ripped out of patty and piece of patty broke off with it.".

• Common Device Name: SPONGE,NEURO,0.5"X3",XR,STRL,LF,10/PK
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19700716
• Report Number: 1417592-2024-00719
• Device Sequence Number: 14378238
• Product Code: HBA
• UDI-Device Identifier: 30080196286533
• UDI-Public: 30080196286533
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 07/09/2024

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: NEUROSPNG09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 54 YR
• Patient Sex: Male