MAUDE Adverse Event Report: MULTIVIEW

Model Number	MVM-HW-LT-01
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device wasn't made available to evaluate.If additional information becomes available a supplement will be filed.
Event or Problem Description
On oct.11, 2017, customer reported that during a biopsy procedure the patient had a rupture of the gel silicone implant.We were unable to obtain additional information.

• Brand Name: MULTIVIEW
• Common Device Name: MULTIVIEW
• MDR Report Key: 7000457
• Report Number: 1220984-2017-00128
• Device Sequence Number: 16531201
• Product Code: LIZ
• UDI-Device Identifier: 15420045504684
• UDI-Public: 15420045504684
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K132136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2017

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: Physician
• Device Model Number: MVM-HW-LT-01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/03/2017
• 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: Other