MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. ASPEN PLASTIBELL 1.1 CM CIRCUMCISION DEVICE; CIRCUMCISION BELL

Model Number	9211
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.Repeated attempts were made for device return and additional information, but without reply.The complaint could not be confirmed, and very little investigation could be performed.Root cause is undetermined.This should be considered the final report.If additional relevant information is identified, it will be submitted in a supplemental report.
Event or Problem Description
Complainant alleges "the circumcision was performed on 6/6, infant discharged on 6/7 with normal assessment post circumcision.Infant returned to (b)(6) ed today 6/17, due to bleeding.Upon assessment, there was an adhesion holding the plastibell on, once the nnp was able to remove the adhesion the plastibell fell off, nnp held pressure and bleeding resolved.

• Brand Name: ASPEN PLASTIBELL 1.1 CM CIRCUMCISION DEVICE
• Common Device Name: CIRCUMCISION BELL
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, INC.; 6945 southbelt dr se; caledonia MI 49316
• Manufacturer Contact: terry hall ; 6945 southbelt dr se; caledonia, MI 49316 ; 6166987100
• MDR Report Key: 22520217
• Report Number: 3002750084-2025-00032
• Device Sequence Number: 18282827
• Product Code: FHG
• UDI-Device Identifier: 00840113231546
• UDI-Public: 00840113231546
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: 9211
• Device Lot Number: 4E01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male