ZIO XT PATCH Adverse Event — Injury (MDR 3007208829-2020-00031)
ZIO XT PATCH Adverse Event — Injury (MDR 3007208829-2020-00031) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ZIO XT PATCH; Generic name: ZIO PATCH; Manufacturer: IRHYTHM TECHNOLOGIES, INC.
| Device | ZIO XT PATCH |
|---|---|
| Generic name | ZIO PATCH |
| Manufacturer | IRHYTHM TECHNOLOGIES, INC |
| Report number | 3007208829-2020-00031 |
| Event type | Injury |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | SKIN IRRITATION IS A KNOWN INHERENT RISK OF THE DEVICE. CLINICAL REF. MANUAL (B)(4) WARNINGS STATE THE FOLLOWING: DO NOT USE THE ZIO XT PATCH ON PATIENTS WITH KNOWN ALLERGIC REACTION TO ADHESIVES OR HYDROGELS OR WITH FAMILY HISTORY OF ADHESIVE SKIN ALLERGIES. PATIENT MAY EXPERIENCE SKIN IRRITATION. IF SKIN IRRITATION SUCH AS SEVERE REDNESS, ITCHING OR ALLERGIC SYMPTOMS DEVELOP, REMOVE THE ZIO XT P |
| Source | openFDA MAUDE (device adverse events) |
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