MAUDE Adverse Event Report: ZIMMER, INC. GEL - ONE 30 MG; ACID, HYALURONIC, INTRAARTICULAR

Lot Number 0018Y05G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Breast Cancer (1759)

Event Type  Injury  

Event Description

Pt reported diagnosed with breast cancer.(b)(6).

• Brand Name: GEL - ONE 30 MG
• Type of Device: ACID, HYALURONIC, INTRAARTICULAR
• Manufacturer (Section D): ZIMMER, INC.
• MDR Report Key: 9202809
• MDR Text Key: 162981176
• Report Number: MW5090436
• Device Sequence Number: 1
• Product Code: MOZ
• UDI-Device Identifier: 87541030091
• UDI-Public: 87541030091
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2019

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
• Device Operator: No Information
• Device Expiration Date: 02/03/2020
• Device Lot Number: 0018Y05G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other