MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; TRAY,CIRCUMCISION,STERILE

Model Number	DYNJ04079Z
Medical Device Problem Codes	Product Quality Problem (1506); Dull, Blunt (2407)
Health Effect - Clinical Code	Genital Bleeding (4507)
Date of Event	01/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2023 during a circumcision the "clinician claimed the blade in the kit wasn't cutting properly and noted the scalpel was blunt, which caused trauma to the cut area requiring the clinician to use gel foam to stop the bleeding." per the facility the patient is reported to be doing "fine now." no additional information is available at this time.A sample was requested, but has not been returned for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, 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 on (b)(6) 2023 during a circumcision the "clinician claimed the blade in the kit wasn't cutting properly and noted the scalpel was blunt, which caused trauma to the cut area requiring the clinician to use gel foam to stop the bleeding.".

• Brand Name: Medline Industries, Inc.
• Common Device Name: TRAY,CIRCUMCISION,STERILE
• 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: 16428109
• Report Number: 1417592-2023-00072
• Device Sequence Number: 11489319
• Product Code: OHG
• UDI-Device Identifier: 10080196819256
• UDI-Public: 10080196819256
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/23/2023

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
• Operator of Device: Health Professional
• Device Model Number: DYNJ04079Z
• Device Catalogue Number: DYNJ04079Z
• Device Lot Number: 22ABM389
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/23/2023
• 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: Male