HOLLISTER PLASTIBELL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-25 for HOLLISTER PLASTIBELL * manufactured by Hollister, Inc..

Event Text Entries

[159385] String broke when tying.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1017396
• MDR Report Key: 245990
• Date Received: 1999-10-25
• Date of Report: 1999-10-01
• Date of Event: 1999-10-01
• Date Added to Maude: 1999-10-27
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HOLLISTER PLASTIBELL
• Generic Name: CIRCUMCISION DEVICE 1.2CM
• Product Code: FHG
• Date Received: 1999-10-25
• Model Number: *
• Catalog Number: *
• Lot Number: 9B11A
• ID Number: *
• Device Expiration Date: 2004-02-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 238316
• Manufacturer: HOLLISTER, INC.
• Manufacturer Address: 2000 HOLLISTER DR. LIBERTYVILLE IL 60048 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-10-25