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	06/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient with mcrc underwent sirt treatment of right lobe (1.17 gbq) on (b)(6) 2019.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: 8704223
• Report Number: 3005579300-2019-00005
• Device Sequence Number: 2212354
• 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