MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,foreign report with the FDA on 2020-02-26 for WITHINGS, WPM05 manufactured by Guangdong Transtek Medical Electronics Co.,ltd.
| Report Number | 3011420269-2020-00001 |
| MDR Report Key | 9754122 |
| Report Source | CONSUMER,DISTRIBUTOR,FOREIGN |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2019-11-30 |
| Date Facility Aware | 2020-01-26 |
| Report Date | 2020-01-29 |
| Date Reported to Mfgr | 2020-01-29 |
| Date Mfgr Received | 2020-01-29 |
| Device Manufacturer Date | 2019-07-23 |
| Date Added to Maude | 2020-02-26 |
| 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. VINCE ZENG |
| Manufacturer Street | ZONE B, NO.105 DONGLI ROAD TORCH DEVELOPMENT DISTRICT |
| Manufacturer City | ZHONGSHAN, GUANGDONG 528437 |
| Manufacturer Country | CH |
| Manufacturer Postal | 528437 |
| Manufacturer G1 | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD |
| Manufacturer Street | ZONE B, NO.105 DONGLI ROAD TORCH DEVELOPMENT DISTRICT |
| Manufacturer City | ZHONGSHAN, GUANGDONG 528437 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 528437 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WITHINGS, WPM05 |
| Generic Name | BLOOD PRESSURE MONITOR |
| Product Code | DXN |
| Date Received | 2020-02-26 |
| Model Number | WPM05 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO.,LTD |
| Manufacturer Address | ZONE B, NO.105 DONGLI ROAD TORCH DEVELOPMENT DISTRICT ZHONGSHAN, GUANGDONG 528437 CH 528437 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |