HORIZON LSO 63X SERIES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for HORIZON LSO 63X SERIES manufactured by Aspen Medical Products.

Event Text Entries

[119206974] I have 2 herniated discs in my lower lumbar. I had to vacate my former residence and so there were a few boxes that contained computer cases. I recently purchased a new back brace through my acupuncturist through a 3rd party dme provider. Though this back brace helped keep my back in a stable form when lifting, it didn't help me lift a box that was about 40-50lbs up into a u haul truck ledge. It went as far as it could and i felt my stomach tighten, and so i immediately let go of it and it dropped about 6-8 inches off the ground. Next day, i was demonstrating the proper way to do a abdominal crunch because my son was heading out the door for football practice. That's when i noticed what happened to be my stomach bulging through the space below my sternum and above my belly button. It poke out about 1-2 inches upward and spanned about 8cm wide and 15 cm high. I thought it was a hernia. I went to see a general surgeon who diagnosed the condition as diastasis recti abdominus. I was advised that the surgery necessary to correct this condition was cosmetic in nature and that i may experience some discomfort. This condition could lead to hernias of a ventral, hiatal, abdominal or umbilical nature. So how did this happen? The back brace i was wearing kept my back straight but it could not keep straight my abdominals, instead of stretched them upward past the front of the back brace as well as resulted in a small hernia near my belly button. A year later, i am feeling much discomfort in the past week. Aside from an overall elevation in my blood pressure from 140 to 200, i feel like i am in a constant state of shock. After i eat, i can hear my stomach slap against my diaphragm as i walk out the door. I experience increased constipation and forced passing of gas since my stomach is experienced difficulty in digesting a meal and it gets bloated. So i have to take probiotics to help pass a long my meal to my other organs which are probably tossing and turning as much as my stomach. It takes me forever to pee and i strain to finish flushing pee out of my bladder. I feel smaller horizontal bubbles or blisters on the side of my abdomen, and it hurts when i apply pressure or try to press it back into the fold it feels it came from. Now i was due for back surgery as well as physical therapy to strengthen my core. Now i cannot and probably never will be able to strengthen my core as any effort to exercise these muscles will cause the split in my abdomen to grow bigger. I can already feel my stomach hanging out below my diaphragm.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5079531
MDR Report Key7842242
Date Received2018-08-31
Date of Report2018-08-29
Date of Event2017-07-24
Date Added to Maude2018-09-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHORIZON
Generic NameORTHOSIS LUMBAR
Product CodeIQE
Date Received2018-08-31
Model NumberLSO 63X SERIES
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerASPEN MEDICAL PRODUCTS


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention; 3. Deathisabilit 2018-08-31

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