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

Model Number	9211
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Complainant alleges "device used during circumcision.Patient was discharged home.Subsequently presented to the emergency department with post-procedure bleeding.Initial evaluation noted a laceration to the glans penis distal to the plastibell device; observation was recommended.Later during hospitalization, concern arose that the device had migrated distally, potentially compromising blood flow.The patient was taken to the operating room for device removal.Intraoperatively, bleeding and worsening hematoma were noted.Patient was discharged home without further known complications.".
Additional Manufacturer Narrative
The device is not available for evaluation.The part number is either 9211 or 9231, which are both the same device just packaged in different quantities, and we chose to report on 9211 as that has higher sales and is more likely correct.No lot number or pictures were provided, and no contact information was provided so that we could reach out for more information.Based on all this, no investigation is possible and the root cause cannot be determined.It is possible that this may have been caused by an improper selection of the bell size.Multiple sizes are offered, with 1.1 cm being the smallest.If a too-small bell is used, it exerts pressure on the sides of the glans and can cause local necrotic changes and periurethral edema.This should be considered the final report.If any additional relevant information is identified, it will be submitted in a supplemental report.

• Brand Name: STORK PLASTIBELL CIRCUMCISION DEVICE 1.1 CM SIZE
• 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: 23009006
• Report Number: 3002750084-2025-00045
• Device Sequence Number: 13389138
• Product Code: FHG
• UDI-Device Identifier: 00840113231546
• UDI-Public: 00840113231546
• Combination Product (Y/N): N
• 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): 09/09/2025

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/09/2025
• 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 Age: 2 DA
• Patient Sex: Male
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White