MAUDE MDR 2913825

MDR report key
2913825
Report number
3005662933-2012-00001
Event key
0
Event type
3
Date of event
2012-11-04
Date received
2012-12-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
420 FT. DUQUESNE BLVD ONE GATEWAY CENTER PITTSBURGH PA 15222 US
Phone
412-412-4122
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BODYMEDIA FITIKK - SENSEWEAR ARMBANDBODYMEDIA, INC.IKKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-12-0601. H

Event Narratives#

D

Patient 1

THE COMPLAINANT REPORTED THE FOLLOWING INFORMATION. SHE HAD EXPERIENCED PAIN IN HER UPPER LEFT ARM AND STOPPED WEARING THE ARMBAND FOR A COUPLE OF DAYS. THE PAIN WORSENED TO THE POINT THAT SHE COULD NOT BEND OR STRAIGHTEN THE ARM. SHE WENT TO AN EMERGENCY ROOM ON (B)(6) 2012, WHERE SHE WAS REPORTEDLY DIAGNOSED WITH BLOOD CLOTS AFTER AN ULTRASOUND AND SEVERAL SCANS. SHE REPORTED THAT THE CEPHALIC AND BRACHIAL VEINS WERE BLOCKED. SHE WAS PRESCRIBED A BLOOD THINNER. SHE REPORTED THAT IT WAS A LOCALIZED BLOOD CLOT, NOT SYSTEMIC, AND WOULD CLEAR UP AFTER 3-4 MONTHS. SHE REPORTED THAT THE EMERGENCY ROOM STAFF NOTED THAT THE CLOT WAS IN AN UNUSUAL PLACE AND WOULD LIKELY HAVE RESULTED FROM DIRECT CONTACT, IMPACT OR INJURY. SHE REPORTED THAT SHE DID NOT HAVE AN INJURY. SHE THEN REPORTED THAT AFTER SHOWING THE ARMBAND TO THE EMERGENCY ROOM STAFF, THEY SAID IT MUST HAVE BEEN THE CAUSE, BECAUSE THAT WAS THE ONLY THING THAT MADE SENSE. SHE ALSO REPORTED HAVING A FULL CT SCAN AND GOING TO THE EMERGENCY ROOM FOR TWO ADDITIONAL VISITS, BOTH UNRELATED TO THE BLOOD CLOT. ONE VISIT WAS FOR A COUGH AND SHE DID NOT MENTION THE REASON FOR THE THIRD VISIT. SHE REPORTED THAT SHE HAD BEEN COUGHING FOR A LONG TIME. AS A RESULT OF STARTING A BLOOD THINNER, SHE WAS TOLD TO DISCONTINUE HER MIGRAINE MEDICATION AND HAD SUFFERED A MIGRAINE SINCE THE EMERGENCY ROOM VISIT WHICH CAUSED HER TO LOSE A WHOLE DAY. SHE MENTIONED THAT HER BLOOD PRESSURE COULD NO LONGER BE TAKEN ON HER LEFT ARM. WHEN ASKED, SHE REPORTED THAT SHE WAS NOT WEARING THE ARMBAND TOO TIGHTLY. UPON REQUESTING THAT THE ARMBAND BE RETURNED, THE COMPLAINANT REPORTED THAT THERE WAS NOTHING WRONG WITH THE ARMBAND AND THAT IT WAS WORKING PROPERLY. MEDICAL RECORDS AND RETURN OF THE ARMBAND HAVE BEEN REQUESTED MULTIPLE TIMES, BUT HAVE NOT BEEN PROVIDED.

N

Patient 1

THE SENSEWEAR ARMBAND ((B)(4) FIT BRANDED VERSION) COLLECTS DATA TO REPORT INFORMATION SUCH AS STEPS TAKEN, CALORIE EXPENDITURE AND PHYSICAL ACTIVITY DURATION TO USERS. THE USER GUIDE INSTRUCTS USERS TO ADJUST THE STRAP, SO IT FITS ON THE ARM COMFORTABLY AND ADVISES IF THE USER FEELS CONSTRICTION OR LOSS OF CIRCULATION AT ANY TIME, THE ADJUSTABLE STRAP SHOULD BE LOOSENED AND RE-FASTENED TO A MORE COMFORTABLE SETTING. UPON INTERNAL REVIEW, THE (B)(4) DATA FOR THE COMPLAINANT SHOWED THAT COMPLAINANT BEGAN WEARING THE ARMBAND IN (B)(6) 2011. HOWEVER, IN THE 60 DAYS PRIOR TO THE EMERGENCY ROOM VISIT THE COMPLAINANT HAD WORN IT INFREQUENTLY AND THE INFORMATION SHE REPORTED REGARDING HER USAGE WAS INCONSISTENT WITH THE (B)(4) DATA. ADDITIONAL USAGE INFORMATION HAS BEEN REQUESTED FROM THE COMPLAINANT. THE INFORMATION PROVIDED DOES NOT REASONABLY SUGGEST THAT THERE WAS A PRODUCT MALFUNCTION. IT HAS BEEN DETERMINED THAT NO FIELD ACTIONS ARE REQUIRED AT THIS TIME REGARDING THIS ISSUE. IF RELEVANT INFORMATION IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.