MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-12 for OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR BP7100 manufactured by Omron Healthcare Co., Ltd..
| Report Number | 8030245-2020-00001 |
| MDR Report Key | 9827556 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-05-06 |
| Date Added to Maude | 2020-03-12 |
| 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. TOMOJI ZUKAWA |
| Manufacturer Street | 53 KUNOTSUBO TERADA-CHO |
| Manufacturer City | MUKO-CITY, KYOTO 6170002 |
| Manufacturer Country | JA |
| Manufacturer Postal | 6170002 |
| Manufacturer G1 | OMRON HEALTHCARE MANUFACTURING VIETNAM CO., LTD. |
| Manufacturer Street | NO. 28 VSIP II, ST. 2, VIETNAM-SINGAPORE INDUS. PARK |
| Manufacturer City | HOA PHU THU DAU MOT CITY, 820000 |
| Manufacturer Country | VM |
| Manufacturer Postal Code | 820000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMRON 3 SERIES UPPER ARM BLOOD PRESSURE MONITOR |
| Generic Name | BLOOD PRESSURE MONITOR |
| Product Code | DXN |
| Date Received | 2020-03-12 |
| Model Number | BP7100 |
| Catalog Number | BP7100 |
| Lot Number | 201905 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRON HEALTHCARE CO., LTD. |
| Manufacturer Address | 53 KUNOTSUBO TERADO-CHO MUKO-CITY, KYOTO 6170002 JA 6170002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-12 |