MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-20 for ZIO XT PATCH N100A102X manufactured by Irhythm Technologies, Inc.
| Report Number | 3007208829-2020-00013 |
| MDR Report Key | 9735264 |
| Report Source | CONSUMER |
| Date Received | 2020-02-20 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2019-11-13 |
| Date Added to Maude | 2020-02-20 |
| 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 | 699 8TH ST SUITE 600 |
| Manufacturer City | SAN FRANCISCO, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 6325749 |
| Manufacturer G1 | IRHYTHM TECH, INC |
| Manufacturer Street | 11085 KNOTT AVENUE SUITE B |
| Manufacturer City | CYPRESS, CA |
| Manufacturer Country | US |
| 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 | 2020-02-20 |
| Returned To Mfg | 2020-01-22 |
| Model Number | N100A102X |
| 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 | 699 8TH ST SUITE 600 SAN FRANCISCO, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-20 |