FDA.reportPublic FDA data

MAUDE MDR 6968885

MDR report key
6968885
Report number
9616086-2017-00018
Event key
0
Event type
3
Date received
2017-10-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
WILLIAM FISHER
Address
1430 DECISION STREET VISTA CA 92081 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CHATTANOOGAINT ADV 2CH COLOR STIM INT'L STDDJO, LLCIMI2755CSR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-10-2301. O

Event Narratives#

D

Patient 1

SERVICE OF SUMMONS WAS MANUFACTURERS FIRST NOTIFICATION OF THIS EVENT. PLAINTIFFS COUNSEL CLAIMS IN THE COMPLAINT THAT " PATIENT THAT DID A SHOULDER TREATMENT IN A REHAB CENTER WITH A CHATTANNOGA DEVICE, GOT A FUNCTIONAL INJURY". QUESTIONNAIRE NOT RECEIVED FROM CLINICIAN AND/OR PATIENT. DEVICE NOT RETURNED TO MANUFACTURER FOR EVALUATION.