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

Model Number DYNJ04079Z

Device Problems Product Quality Problem (1506); Dull, Blunt (2407)

Patient Problem Genital Bleeding (4507)

Event Date 01/31/2023

Event Type  Injury  

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 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.
• Type of Device: 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
• MDR Text Key: 310129258
• Report Number: 1417592-2023-00072
• Device Sequence Number: 1
• Product Code: OHG
• UDI-Device Identifier: 10080196819256
• UDI-Public: 10080196819256
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYNJ04079Z
• Device Catalogue Number: DYNJ04079Z
• Device Lot Number: 22ABM389
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male