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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: REDFIELD CROP INFRARED COAGULATOR ABLATION OF ANAL HSIL
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REDFIELD CROP INFRARED COAGULATOR ABLATION OF ANAL HSIL Back to Search Results
Model Number IRC2100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dehydration (1807); No Code Available (3191)
Event Date 01/29/2017
Event Type  Injury  
Event Description
Anchor study: (b)(4) research study. Attribute to gr. 3 metabolism and nutrition disorders - other, specify diabetes. Admitted to the hospital (b)(6) 2017 for new onset of diabetes and dehydration. Not related to study treatment. Prior diagnosis of pre-diabetes. Treatment arm (hsil treatment with choice of ablative devices or topical cream every 6 months if biopsy). Date of use: start date of first course: (b)(6) 2016. Start date of course associated with expediated report: (b)(6) 2016. Start date of primary ae: (b)(6) 2017. End date of primary ae: (b)(6) 2017. Course number on which event(s) occurred: 2. Total number of courses to date: 3. Was investigational agent(s) administered on this study: unk.
 
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Brand NameINFRARED COAGULATOR ABLATION OF ANAL HSIL
Type of DeviceINFRARED COAGULATOR ABLATION OF ANAL HSIL
Manufacturer (Section D)
REDFIELD CROP
MDR Report Key6456433
MDR Text Key71824654
Report NumberMW5068878
Device Sequence Number1
Product Code KNS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberIRC2100
Was Device Available for Evaluation?
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/31/2017 Patient Sequence Number: 1
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