[17139217]
Use of the mia by a person with 2 shunt or 2 heart pacemaker could result in serious health complications, including death. An appropriate warning about the unit's magnetic quality must be placed on the mia and in promotional literature. The company agreed to do so (exhibit "b"), but has not done so. A personal hygiene appliance for facial/body cleansing. It contains a strong magnetic necessary for electrically charging the appliance. It is called the "mia" by clarasonic. "on (b)(6) 2010, (b)(6) was hospitalized for a neurosurgical procedure to help alleviate her diagnosed normal pressure hydrocephalus (n. P. H. ). During her first follow-up examination, the doctor discovered the shunt's setting had changed from what it was when originally placed in her head. The doctor who examined her at that time re-set the shunt setting. We asked why it had changed, and we were told that sometimes a new one could possibly change, if defective, or if it had been subjected to a magnetic force that would change the setting. Later, at her subsequent post-op examination, the shunt again was found to have changed settings. Again the shunt was re-set. During the two-week interim, (b)(6) complained of a continuous headache, which we didn't know was shunt-related or from a migraine or sinus condition. Incorrect setting of the shunt valve could affect the rate of spinal fluid flow from the brain and result in the formation of subdural hematomas. (b)(6) called the doctor's office and reported her continuing headache. The doctor directed her to have a ct scan. She did so, and two subdural hematomas were detected. We immediately went to (b)(6) and she was admitted for observation, evaluation, and further testing - including the shunt mechanism, which, again had to be re-set. (b)(6)'s neurosurgeon contacted the shunt manufacturer's representative and explained briefly what had been occurring. The representative agreed to see (b)(6) in the hospital to test the shunt with an extremely sensitive instrument to determine whether it was functioning as it should. While in the hospital, the shunt appeared to maintain its most recent setting. After various tests at the hospital, dr. (b)(6) agreed to discharge (b)(6), directing she have another ct scan three days later, and returning to the doctor's office to hear the results of the scan. The hematomas had remained the same with no change. While at home, (b)(6) pursued her regular regimen of hygiene which included use of your clarasonic (mia). Still suffering from headaches, sue returned to dr. (b)(6)'s office. Prior to this visit, (b)(6) discovered that your unit was recharged through a magnetic connection. We took both the cord assembly and the unit itself to dr. (b)(6)'s office. I asked her to test both pieces with the shunt adjustment equipment. In doing so, we found that both magnetized pieces dramatically affected the measuring equipment - to the extent the shunt in (b)(6)'s head would have been adversely affected, resulting in changes in the rate of spinal fluid flow through the shunt! "
Patient Sequence No: 1, Text Type: D, B5