MPHI F9000221

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-03 for MPHI F9000221 manufactured by Asa Srl.

Event Text Entries

[90932923] Adequate information to complete the investigation on the case is not yet available. The investigation activities continue and will follow follow-up
Patient Sequence No: 1, Text Type: N, H10


[90932924] The patient reported back pain and skin rash on the back of the neck after the 3th session of the therapy
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004724437-2017-00002
MDR Report Key6998574
Report SourceDISTRIBUTOR
Date Received2017-11-03
Date of Report2017-11-30
Date of Event2017-06-07
Date Mfgr Received2017-10-06
Device Manufacturer Date2015-02-27
Date Added to Maude2017-11-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationSERVICE PERSONNEL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. LUCIO ZAGHETTO
Manufacturer StreetVIA ALESSANDRO VOLTA 9
Manufacturer CityARCUGNANO, 36057
Manufacturer CountryIT
Manufacturer Postal36057
Manufacturer G1ASA SRL
Manufacturer StreetVIA ALESSANDRO VOLTA 9
Manufacturer CityARCUGNANO, 36057
Manufacturer CountryIT
Manufacturer Postal Code36057
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMPHI
Generic NameLASER THERAPY
Product CodeILY
Date Received2017-11-03
Model NumberF9000221
Catalog NumberMPHI
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerASA SRL
Manufacturer AddressVIA ALESSANDRO VOLTA 9 ARCUGNANO, 36057 IT 36057


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-11-03

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