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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC HYDROMARK BREAST BIOPSY SITE MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE

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DEVICOR MEDICAL PRODUCTS INC HYDROMARK BREAST BIOPSY SITE MARKER MARKER, RADIOGRAPHIC, IMPLANTABLE Back to Search Results
Model Number 4010-02-15-T1
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414); Patient Problem/Medical Problem (2688)
Event Date 06/05/2018
Event Type  Injury  
Manufacturer Narrative
The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for a least 6 weeks, and be permanently visible by x-ray and mri. The removal of the hydromark device was delayed since the patient did not have any allergy symptoms since she was discharged from the hospital on (b)(6) 2018. The patient went through a fast tracked mastectomy on (b)(6) 2018 and the marker was removed. The delay in surgery from (b)(6) 2018 (impact date) to (b)(6) 2018, is due to through check of every surgical equipment and medications to be used to rule out presence of peg prior to surgery. No additional information about the patient is known at this time. "per review by our medical director", hypersensitivity to the hydromark biogel is extraordinarily unlikely as the device remained in vivo until removal. If the offending agent remained in the patient, the reported reaction would have been expected to be ongoing. " this event has been determined to be reportable pursuant to 21 cfr 803. As such, we are submitting this medwatch report.
 
Event Description
It was reported by the doctor, post procedure, hydromark was inserted into the patient without complications on (b)(6) 2018. After the procedure the patient was discharged home on the same day. The patient is known to have an allergy to polyethylene glycol (peg). When she got home she felt tingling at the site of the hydromark and was aware she was having an allergic reaction. She self-administered her epipen. The symptoms did not diminish so she self-administered a 2nd dose of her epipen. She did not alert the hospital. Shortly after but on the same day she arrived at the hospital a and e department and was treated as anaphylactic shock for a severe allergic reaction. She stayed in itu for 2 days. She was the transferred to the ward for 1 day. She was discharged on friday (b)(6). Procedure was completed with the device. Patient complication: medical/surgical treatment was required to resolve consequence. Additional details: the surgical wash used prior to the procedure was ecolab hydrex pink which also contains polyethylene glycol.
 
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Brand NameHYDROMARK BREAST BIOPSY SITE MARKER
Type of DeviceMARKER, RADIOGRAPHIC, IMPLANTABLE
Manufacturer (Section D)
DEVICOR MEDICAL PRODUCTS INC
300 e-business way
fifth floor
cincinnati OH 45241
Manufacturer (Section G)
DEVICOR MEDICAL PRODUCTS DE MEDICAL
sor juana ines de la cruz
#20152 4-b, parque industrial
tijuana, baja california 22440
MX 22440
Manufacturer Contact
shawna rose
300 e-business way
fifth floor
cincinnati, OH 45241
5138649178
MDR Report Key7674287
MDR Text Key113558484
Report Number3008492462-2018-00050
Device Sequence Number1
Product Code NEU
UDI-Device Identifier00841911101468
UDI-Public(01)00841911101468(17)210109(10)200044197
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K121113
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/10/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/09/2021
Device Model Number4010-02-15-T1
Device Catalogue Number4010-02-15-T1
Device Lot Number200044197
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2018
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: 07/10/2018 Patient Sequence Number: 1
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