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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PALETTE LIFE SCIENCES DEFLUX; DEFLUX INJECTABLE GEL
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PALETTE LIFE SCIENCES DEFLUX; DEFLUX INJECTABLE GEL Back to Search Results
Model Number 011504
Device Problem Insufficient Information (3190)
Patient Problems Calcium Deposits/Calcification (1758); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
Parent reported on (b)(6) that female child was misdiagnosed with a "stone" and experienced complications during ureteroscopy during search for stones.Child actually had calcification around unreported deflux injection.
 
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Brand Name
DEFLUX
Type of Device
DEFLUX INJECTABLE GEL
Manufacturer (Section D)
PALETTE LIFE SCIENCES
27 e cota st
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 Key14688094
MDR Text Key294057770
Report Number3014909464-2022-00003
Device Sequence Number1
Product Code LNM
UDI-Device Identifier00850004725009
UDI-Public00850004725009
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number011504
Device Catalogue Number3001-2
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2022
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 Number1
Patient Outcome(s) Other;
Patient SexFemale
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