MAUDE Adverse Event Report: BRIGGS MEDICAL SERVICE COMPANY PLASTIBELL CIRCUMCISION DEVICE; BELL, CIRCUMCISION

Lot Number 5D06

Device Problems Break (1069); Scratched Material (3020)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/11/2017

Event Type  malfunction  

Event Description

During the circumcision when using a plastibell device the tab on the plastibell is snapped off and usually leaves a smooth finish.However, in this case, it didn't snap evenly and caused sharp edges to remain behind.This did not cause patient injury/harm to the patient.

• Brand Name: PLASTIBELL CIRCUMCISION DEVICE
• Type of Device: BELL, CIRCUMCISION
• Manufacturer (Section D): BRIGGS MEDICAL SERVICE COMPANY; waukegan IL 60085
• MDR Report Key: 7079045
• MDR Text Key: 93752162
• Report Number: MW5073715
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Lot Number: 5D06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 YR
• Patient Weight: 4