MAUDE Adverse Event Report: PALETTE LIFE SCIENCES SOLESTA

Model Number 011506

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

Patient Problem Cyst(s) (1800)

Event Type  Injury  

Event Description

International journal of gynecological pathlogy - 001:1-4 describes incident of female patient diagnosed with 'vaginal cyst'.

• Brand Name: SOLESTA
• Type of Device: 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
• MDR Text Key: 294883215
• Report Number: 3014909464-2021-00002
• Device Sequence Number: 1
• Product Code: LNM
• UDI-Device Identifier: 00850004725016
• UDI-Public: 00850004725016
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other