HOLLISTER PLASTI-BELL 1.1 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-07-21 for HOLLISTER PLASTI-BELL 1.1 * manufactured by Tri-state Hospital Supply.

Event Text Entries

[516789] Circumcision procedure was performed using a 1. 1 hollister plasti-bell device. Upon application of the cotton ligature, the plasti-bell ring disrupted causing a deep circumferential laceration of the glans penis. Oozing was controlled using direct pressure and measured blood loss was 3. 5 ml. Inspection of the plasti-bell showed disruption at both lateral seals of the plastic ring. The nicu neonatologist was consulted and the infant was transferred to a higher level of care hospital to be evaluated and managed by pediatric urology and plastic surgery.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1039828
• MDR Report Key: 751390
• Date Received: 2006-07-21
• Date of Report: 2006-07-21
• Date of Event: 2006-07-16
• Date Added to Maude: 2006-08-18
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HOLLISTER PLASTI-BELL
• Generic Name: CIRCUMCISION RING
• Product Code: FHG
• Date Received: 2006-07-21
• Model Number: 1.1
• Catalog Number: *
• Lot Number: 5X01
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 739203
• Manufacturer: TRI-STATE HOSPITAL SUPPLY
• Manufacturer Address: 301 CANTRELL DRIVE HOWELL MI 48843 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2006-07-21