[2717215]
Use of the mia by a person with a shunt or a heart pace maker 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. Location of injury: head. Type of injury: bleeding, internal organ injury. Product category: personal care. 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 clarisonic. I am writing you on behalf of my wife, (b)(6), and myself. Several months ago, she purchased one of your clarasonic units (the "mia") through (b)(6). She had been using it quite frequently - several times a week. On (b)(6) 2010, (b)(6) was hospitalized for a neurosurgical procedure to help alleviate her diagnosed normal pressure hydrocephalus (n. P. H. ). The surgery involves incisions made in her head, neck area, and abdomen. A shunt is placed under her scalp and is connected to a long tube that drains excess spinal fluid (to relieve pressure build-up) from her brain to the abdominal cavity, where the fluid is absorbed back into the body. This procedure is generally accepted by the medical community and used universally to address the symptoms (gait, incontinence, and short-term memory loss) generally associated with nph. Two of the most dangerous side effects of such surgery are (1) infection, and (2) subdural hematomas. Ideally, this particular shunt and valve assembly (medtronic) is adjustable without necessitating further surgery by using equipment powered by a magnet. (b)(6) returned home from the hospital after a three-day stay, and began her recovery from the surgery. We were told that if at any time she would require a magnetic resonance imaging (mri) test on any part of her body, it would be necessary to re-program her shunt because of the imaging's magnetic quality. During her first follow-up examination, the doctor discovered the shunt's setting had changed from what is 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. (b)(6) and i were rather upset, since we realized a shunt that might be defective necessitated surgical replacement. Of course this is not a pleasant procedure to undergo. Again the shunt was re-set. The doctor said to call her in two weeks to tell her how (b)(6) felt. 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. In correct 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 the (b)(6) hospital emergency room, and she was admitted for observation, evaluation, and further testing - including the shunt mechanism, which, again had to be re-set. (b)(6) 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 test 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, (b)(6) returned to dr. (b)(6) 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) 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) head would have been adversely affected, resulting in changes in the rate of spinal fluid flow through the shunt. Could such a change cause a subdural hematoma. There's no question in our minds that the answer is "yes. " nowhere in the brochures that accompanied your clarasonic (mia) is there any word of caution about the magnetic quality of the unit. None of your promotional material indicates need for such caution. Had there been, (b)(6) certainly would not have used the clarasonic (mia). As you can understand, many dollars have been spent, time invested by professional personnel, and quality of life impacted by unsettled nerves as a result of what (b)(6) has experienced. Additionally, (b)(6) can no longer use the "mia", obviously, and she has lot the investment she had in the unit. We have chosen to omit many details (available in (b)(6) medical files at (b)(6) hospital, at the (b)(6), and in the offices of medical caregivers associated with (b)(6) care) so you can better understand our plight. At this point, it seems to us you have been negligent in not cautioning consumers as to the magnetic properties of your clarasonic mia. We hope no other person has to suffer through such an ordeal. We should like to hear from you at your earliest convenience.
Patient Sequence No: 1, Text Type: D, B5