MAUDE Adverse Event Report: SIRTEX WILMINGTON LLC SIR SHPERES Y-90 MICROSPHERES; YTTRIUM-90 RESIN MICROSPHERES

Model Number	SIR-Y001
Health Effect - Clinical Code	Rash (2033)
Date of Event	04/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient with primary hcc underwent sirt treatment of right lobe (1.48 gbq) on (b)(6) 2019.Approximately 2 weeks after sirt treatment patient presented with diffuse rash (face, chest and back) that required treatment (grade 2).Prescribed treatment included: medrol dose pack, protonix, zantac, oxycodone and zofran.

• Brand Name: SIR SHPERES Y-90 MICROSPHERES
• Common Device Name: YTTRIUM-90 RESIN MICROSPHERES
• Manufacturer (Section D): SIRTEX WILMINGTON LLC; 16 upton dr.; no. 2-4; wilmington MA 01887
• MDR Report Key: 8704224
• Report Number: 3005579300-2019-00004
• Device Sequence Number: 19293863
• Product Code: NAW
• UDI-Device Identifier: M425SIRY0010
• UDI-Public: M425SIRY0010
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P990065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/17/2019

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 Model Number: SIR-Y001
• Device Catalogue Number: SIR-Y001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/17/2019
• 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: Required Intervention