MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-08 for MANUAL PATIENT ROTATION BED 7714P manufactured by Foshan R. Poon Medical Products Co., Ltd..
[63801424]
Per importer's mdr: (b)(6) 2012 - (b)(6); the dealer reported that the 7714p trapez homecare bed had one bent leg. There was no pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000282279-2013-00012 |
| MDR Report Key | 6210618 |
| Date Received | 2013-05-08 |
| Date of Report | 2013-05-07 |
| Date Mfgr Received | 2013-04-29 |
| Date Added to Maude | 2016-12-28 |
| 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. KEVIN WALLS |
| Manufacturer Street | 33 GOLDEN EAGLE LN. |
| Manufacturer City | LITTLETON CO 80127 |
| Manufacturer Country | US |
| Manufacturer Postal | 80127 |
| Manufacturer Phone | 7209625412 |
| Manufacturer G1 | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. |
| Manufacturer Street | NEW CITY DISTRICT, DANZAO |
| Manufacturer City | NANHAI, FOSHAN 528216 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 528216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MANUAL PATIENT ROTATION BED |
| Generic Name | BED |
| Product Code | INY |
| Date Received | 2013-05-08 |
| Model Number | 7714P |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FOSHAN R. POON MEDICAL PRODUCTS CO., LTD. |
| Manufacturer Address | NEW CITY DISTRICT, DANZAO NANHAI, FOSHAN 528216 CH 528216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-08 |