REVEALER UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-11-18 for REVEALER UNK manufactured by Unk.

Event Text Entries

[17516002] Rptr was referred to a vascular surgeon and a cardiologist because of blood pressure problems. The vascular surgeon implanted device. After implantation rptr could feel it "tearing inside" and had extreme pain inside their breast. Rptr thought their breast implants were ruptured. The device was removed 2 weeks later. Rptr activated device twice and then the 3rd time they had to go to the dr. At that time they found out the mfr reads the device, not their physician. Rptr didn't realize mfr reps were that involved and in the or when device was implanted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1026789
MDR Report Key428791
Date Received2002-11-18
Date of Report2002-11-18
Date of Event2002-08-01
Date Added to Maude2002-11-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameREVEALER
Generic NameHEART + BP MONITOR IMPLANTABLE
Product CodeDXH
Date Received2002-11-18
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
ID NumberUNK
OperatorHEALTH PROFESSIONAL
Device Availability*
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key417814
ManufacturerUNK
Manufacturer AddressUNK UNK *


Patients

Patient NumberTreatmentOutcomeDate
10 2002-11-18

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