Patient called to report an adverse event involving her boston scientific mini heart monitor.Patient stated after about 2 weeks of use, she started itching under the pad.Patient stated she called the manufacturer and was sent another pad that was hypoallergenic.She said when she removed the old pad to put on the new pad, she noticed dried blood around the patch.Patient said she contacted the manufacturer and was told she would receive a call back and that she waited 3 days and never heard from anyone.Patient said she decided to take off the monitor herself because of the irritation and found bleeding sores under the patch with blood around the edges.Patient said her skin was raw and red.Reference report: mw5147890.
|