OMNISENSE 7000P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-13 for OMNISENSE 7000P manufactured by Sunlight Medical Inc.

Event Text Entries

[15162482] This female pt is a survivor of child abuse by battering. She had multiple fractures and soft tissue injuries at her diagnosis at 2 months of age including left pleural effusion and retroperitoneal hematoma. Her fractures included many ribs and spine and both femurs. Pt has been followed with dexa scan densitometry since then by a neonatologist. All dexa results have been "normal" based on limited comparison databases for age-matched pts. In 2007, the same neonatologist decided to do radial and tibia ultrasounds as well as the densitometry. Densitometry showed wonderful results for bone density -lumbar spine 84th percentile; femoral neck 46th percentile; total body calcium 95th percentile; total body bmd 50th percentile. The sos bone ultrasound device , omnisense 7000p, showed radial 7th percentile/-1. 5 z score and tibial sos 0 percentile/-3. 5 z score. How can this be true? Manufacturer of ultrasound device claims densitometry is unnecessary since osteoporosis is a systemic disease affecting all bones in body. Neonatologist has advised family child is at high risk of fractures based only on this ultrasound result. Pt is in gymnastics, now with no fractures since her battering at 2 months of age. This discrepancy with densitometry results previously reported in medical literature. See gianni ml et al. Quantitative ultrasound and dual-energy x-ray absorptiometry in bone status assessment of ex-preterm infants. Arch dis child fetal neonatal edd 2008;93:f146-147. "no significant correlation between spinal dxa and sos measurements at each skeletal site was found. " as pediatrician, i am distressed parents are given ludicrous information disregarding the better testing that is available. Dates of use: months to years. Diagnosis or reason for use: history of fractures in infancy, court room testimony. Event abated after use stopped: no.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5011562
MDR Report Key1404651
Date Received2009-06-13
Date of Report2009-06-13
Date of Event2007-03-23
Date Added to Maude2009-06-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameOMNISENSE 7000P
Generic NameBONE ULTRASOUND
Product CodeKGI
Date Received2009-06-13
Model Number7000P
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerSUNLIGHT MEDICAL INC
Manufacturer AddressSOMERSET NJ US


Patients

Patient NumberTreatmentOutcomeDate
10 2009-06-13

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