EXOS 310-52-1111

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-06-21 for EXOS 310-52-1111 manufactured by Djo, Llc.

Event Text Entries

[111944791] Complaint received that alledges "on (b)(6) reported decreased sensation on the back of my right thumb. Now over 2 weeks later i am still left with the same altered sensation/numbness. I am still in the brace. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2018-00015
MDR Report Key7626621
Report SourceCONSUMER
Date Received2018-06-21
Date of Report2018-06-21
Date of Event2018-06-12
Date Added to Maude2018-06-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactWILLIAM FISHER
Manufacturer Street1460 DECISION STREET
Manufacturer CityVISTA CA 920819663
Manufacturer CountryUS
Manufacturer Postal920819663
Manufacturer G1DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.
Manufacturer StreetCARRETERA LIBRE TIJUANA TECATE 20230 SUBMETROPOLI EL FLORIDO
Manufacturer CityTIJUANA, MX
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXOS
Generic NameSHRT ARM FRACTURE BRACE, BLK, RT, M
Product CodeIQI
Date Received2018-06-21
Model Number310-52-1111
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1460 DECISION STREET VISTA CA 920819663 US 920819663


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-06-21

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