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

Model Number	4010-02-15-T1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Reaction (2414); Patient Problem/Medical Problem (2688)
Date of Event	06/05/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 7674287
• Report Number: 3008492462-2018-00050
• Device Sequence Number: 789534
• Product Code: NEU
• UDI-Device Identifier: 00841911101468
• UDI-Public: (01)00841911101468(17)210109(10)200044197
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2018

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: Health Professional
• Device Expiration Date: 01/09/2021
• Device Model Number: 4010-02-15-T1
• Device Catalogue Number: 4010-02-15-T1
• Device Lot Number: 200044197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization