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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK BIOPSY SITE MARKER

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DEVICOR MEDICAL PRODUCTS, INC. HYDROMARK BIOPSY SITE MARKER Back to Search Results
Model Number 4010-02-15-T3
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Date 02/24/2017
Event Type  Injury  
Manufacturer Narrative
Patient is having testing performed to determine what she is allergic to. Information regarding clip metal (titanium) has been provided to rule out potential nickel sensitivity. Lidocaine and epinephrine are also being examined as potential allergens as they are commonly used in medical procedures. Patient was treated with prednisone and benadryl for symptoms and sent home. Her pathology results indicate cancer, so she will undergo additional surgery to remove lesion, which will also remove marker at same time. Follow up patient details are not available at this time. It is unknown if our device is a contributor to this event or not. As such, due to the medical intervention and potential of more serious reaction, pursuant to 21 cfr 803, we are submitting this medwatch report. Device not returned.
 
Event Description
The sales rep reported possible allergic reaction to hydromark. Patient has hives and rash over body. Patient was see at the er over the weekend. A benadryl drip was administered in the er and the patient was put on prednisone.
 
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Brand NameHYDROMARK BIOPSY SITE MARKER
Type of DeviceBIOPSY SITE MARKER
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS, INC.
300 e-business way
fifth floor
cincinnati OH 45241
Manufacturer (Section G)
MICRO STAMPING CORPORATION
12955 starkey rd
suite 3700
largo FL 33773
Manufacturer Contact
shawna rose
300 e-business way
fifth floor
cincinnati, OH 45241
5138649178
MDR Report Key6434910
MDR Text Key70861424
Report Number3008492462-2017-00018
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 02/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4010-02-15-T3
Device Catalogue Number4010-02-15-T3
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/26/2017 Patient Sequence Number: 1
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