MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-07-11 for 1-CHANNEL HOLTER MONITOR CARDIOKEY 100-0030-01 manufactured by Braemar Manufacturing, Llc.
| Report Number | 2133409-2019-00008 |
| MDR Report Key | 8780756 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-07-11 |
| Date of Report | 2019-07-11 |
| Date of Event | 2019-06-04 |
| Date Mfgr Received | 2019-06-14 |
| Date Added to Maude | 2019-07-11 |
| 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 | MS. BEVERLY OKOH |
| Manufacturer Street | 1285 CORPORATE CENTER DRIVE SUITE 150 |
| Manufacturer City | EAGAN MN 55121 |
| Manufacturer Country | US |
| Manufacturer Postal | 55121 |
| Manufacturer G1 | BRAEMAR MANUFACTURING, LLC |
| Manufacturer Street | 1285 CORPORATE CENTER DRIVE SUITE 150 |
| Manufacturer City | EAGAN MN 55121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1-CHANNEL HOLTER MONITOR CARDIOKEY |
| Generic Name | 1-CHANNEL HOLTER MONITOR CARDIOKEY |
| Product Code | MWJ |
| Date Received | 2019-07-11 |
| Model Number | 100-0030-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRAEMAR MANUFACTURING, LLC |
| Manufacturer Address | 1285 CORPORATE CENTER DRIVE SUITE 150 EAGAN MN 55121 US 55121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-11 |