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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. CURAD XEROFORM; DRESSING, WOUND, DRUG
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MEDLINE INDUSTRIES INC. CURAD XEROFORM; DRESSING, WOUND, DRUG Back to Search Results
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Fainting (1847); Nausea (1970); Vomiting (2144); Burning Sensation (2146); Tingling (2171); Numbness (2415); Shaking/Tremors (2515)
Date of Event 03/17/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Day 1 - xeroform was placed over a deep cut on my finger.Immediately my finger started burning, i became nauseous, vomited, and felt like fainting.This lasted approximately 45 minutes.Day 2 - xeroform was placed over the cut again.Immediately my finger began burning.Soon after i was nauseous and felt like i was going to faint.Approximately 25 minutes later i began trembling and my face became numb and tingly.The xeroform was immediately removed, my finger was flushed with water and wiped to remove any residue, and within minutes the burning subsided and other symptoms started lessening.It was about an hour later that i finally felt like i was okay.Quantity: 1 patch.Frequency: as needed.How was it taken or used: transdermal.Date the person first started taking or using the product: (b)(6) 2018.Date the person stopped taking or using the product: (b)(6) 2018.Did the problem stop after the person reduced the dose or stopped taking or using the product? yes.Did the problem return if the person started taking or using the product again? doesn't apply.Do you still have the product in case we need to evaluate it? no.
 
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Brand Name
CURAD XEROFORM
Common Device Name
DRESSING, WOUND, DRUG
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
MDR Report Key7366152
Report NumberMW5076065
Device Sequence Number9757669
Product Code FRO
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 03/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/22/2018
Patient Sequence Number1
Patient Age32 YR
Patient Weight17
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