COMPEX 2540660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-07-10 for COMPEX 2540660 manufactured by Djo, Llc.

Event Text Entries

[79571524] Plaintiffs counsel claims in the complaint that "electrode stimulation proved to be dangerously high, causing mr. (b)(6)'s bicep to forcefully and unnaturally contract to a dangerous degree and proceeded to injure our client. Impression: rotator cuff tendinosis with mild intrasubstance partial tearing. There is no full thickness tear present. Mild subacromial and subdeltoid bursitis. There is a complete tear of the biceps tendon with the proximal portion of the biceps extending anteriorly and superior to the subscapularis muscle bundle. Superior labral tearing. Glenohumeral joint effusion. Acromioclavicular joint hypertrophy and inflammation". Questionnaire not received from clinician and/or patient. Device not returned to manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9616086-2017-00011
MDR Report Key6697220
Report SourceOTHER
Date Received2017-07-10
Date of Report2017-07-10
Date of Event2016-09-17
Date Added to Maude2017-07-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationATTORNEY
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactWILLIAM FISHER
Manufacturer Street1430 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 City22244
Manufacturer CountryMX
Manufacturer Postal Code22244
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOMPEX
Generic NameCOMPEX WIRELESS USA COMPLETE SET
Product CodeNGX
Date Received2017-07-10
Model Number2540660
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDJO, LLC
Manufacturer Address1430 DECISION STREET VISTA CA 920819663 US 920819663


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-07-10

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.