A 30-year-old male allegedly experienced a serious injury noted as redness and an itching sensation with the use of the 3m¿ ecg monitoring electrodes, foam diaphoretic, 2228 lot: 20220504.The area was wiped with alcohol and an intravenous infusion of anti-allergic medicine was administered.No additional information is available.
|
H10: product sample was not returned to 3m for analysis.Without a sample, it is not possible to perform any tests to determine if the device met specifications.Without additional information, it is not possible to definitively determine the root cause.The instructions for use states, 3m¿ ecg monitoring electrodes, foam diaphoretic, 2228 are disposable, intended for single use, and has been tested for up to 3 days wear.For proper skin management and to minimize skin irritation: avoid placing an electrode on an irritated skin site.Do not abrade a skin site more than one time.Avoid removing electrodes frequently and/or reapplying to the same skin site.Avoid placing electrodes on skin still wet from an alcohol wipe (dry thoroughly).Assess electrode sites periodically.
|