MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-17 for AQUASENSE 770-525 manufactured by R.poon Medical Products (mingguang) Company Limite.
| Report Number | 3010865207-2020-00001 |
| MDR Report Key | 9716662 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-02-17 |
| Date of Report | 2020-02-17 |
| Date of Event | 2019-11-22 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-02-17 |
| 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 | KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LANE |
| Manufacturer City | LITTLETON, CO |
| Manufacturer Country | US |
| Manufacturer Phone | 9625412 |
| Manufacturer G1 | R.POON MEDICAL PRODUCTS (MINGGUANG) COMPANY LIMITE |
| Manufacturer Street | NO.116 QICANG ROAD |
| Manufacturer City | MINGGUANG ANHUI, 239400 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 239400 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AQUASENSE |
| Generic Name | BATH SEAT |
| Product Code | ILS |
| Date Received | 2020-02-17 |
| Model Number | 770-525 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | R.POON MEDICAL PRODUCTS (MINGGUANG) COMPANY LIMITE |
| Manufacturer Address | NO.116 QICANG ROAD MINGGUANG ANHUI, 239400 CH 239400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-02-17 |