MAUDE Adverse Event Report: PALETTE LIFE SCIENCES SOLESTA

Model Number	011506
Health Effect - Clinical Code	Cyst(s) (1800)
Type of Reportable Event	Serious Injury
Event or Problem Description
International journal of gynecological pathlogy - 001:1-4 describes incident of female patient diagnosed with 'vaginal cyst'.

• Brand Name: SOLESTA
• Common Device Name: SOLESTA
• Manufacturer (Section D): PALETTE LIFE SCIENCES; 27 e. cota street; suite 402; santa barbara CA 93101
• Manufacturer (Section G): PALETTE LIFE SCIENCES; 27 e cota st; suite 402; santa barbara CA 93101
• Manufacturer Contact: david goodnough ; 27 e cota st; suite 402; santa barbara, CA 93101 ; 8058697087
• MDR Report Key: 14688194
• Report Number: 3014909464-2021-00002
• Device Sequence Number: 6636962
• Product Code: LNM
• UDI-Device Identifier: 00850004725016
• UDI-Public: 00850004725016
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Model Number: 011506
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown