HISTOFREEZER H-106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-12-17 for HISTOFREEZER H-106 manufactured by Utermohlen, Nv.

Event Text Entries

[111625] Physician got liquid from a cryogenic wart treatment in his eye. Physician did not use the device according to the package insert. Dr shook the unit while charging the foam applicator and a drop of liquid got into his eye. Minor discomfort was experienced which the physician felt could be the result of flushing his eye with water in accordance with the msds procedures.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2528909-1997-90001
• MDR Report Key: 139144
• Date Received: 1997-12-17
• Date of Report: 1997-12-17
• Date of Event: 1997-12-10
• Date Facility Aware: 1997-12-10
• Report Date: 1997-12-17
• Date Reported to FDA: 1997-12-17
• Date Reported to Mfgr: 1997-12-17
• Date Added to Maude: 1997-12-23
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• 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: HISTOFREEZER
• Generic Name: CRYOGENIC WART TREATMENT
• Product Code: GXH
• Date Received: 1997-12-17
• Model Number: NA
• Catalog Number: H-106
• Lot Number: 101302276
• ID Number: *
• Device Expiration Date: 2000-08-01
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: 1.5 YR
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 135867
• Manufacturer: UTERMOHLEN, NV
• Manufacturer Address: P.O. BOX 85161 AD UTRECHT NL 3508

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-12-17