MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-08 for ZIO XT PATCH manufactured by Irhythm Technologies, Inc.
[138343844]
Skin irritation is a known inherent risk of the device. Clinical ref manual ((b)(4)) warnings states 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 patch from the patient's chest.
Patient Sequence No: 1, Text Type: N, H10
[138343845]
Patient contacted irhythm regarding a probable contact dermatitis for which medical attention was sought and treatment was prescribed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208829-2019-00014 |
| MDR Report Key | 8406114 |
| Report Source | CONSUMER |
| Date Received | 2019-03-08 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-02-13 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-12-26 |
| Date Added to Maude | 2019-03-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RICH LAGUNA |
| Manufacturer Street | 650 TOWNSEND SUITE 500 |
| Manufacturer City | SAN FRANCISCO CA 94103 |
| Manufacturer Country | US |
| Manufacturer Postal | 94103 |
| Manufacturer Phone | 4156325749 |
| Manufacturer G1 | IRHYTHM TECH, INC |
| Manufacturer Street | 11085 KNOTT AVENUE SUITE B |
| Manufacturer City | CYPRESS CA 90630 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZIO XT PATCH |
| Generic Name | ZIO PATCH |
| Product Code | DSH |
| Date Received | 2019-03-08 |
| Returned To Mfg | 2019-02-16 |
| Lot Number | N852766165 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IRHYTHM TECHNOLOGIES, INC |
| Manufacturer Address | 650 TOWNSEND SUITE 500 SAN FRANCISCO CA 94103 US 94103 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-08 |