MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2013-07-19 for WHEELCHAIR ACCESSORY 7740P manufactured by Foshan R. Poon Medical Products Co., Ltd..
[63753835]
Per importer's mdr: mdr decision date: (b)(6) 2013. No serious injury alleged. Malfunction alleged. Ivc territory business manager states where the top of the vertical portion fit into the upper, the slot has expanded, making the trapeze wobbly. Mdr filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000282279-2013-00098 |
| MDR Report Key | 6210624 |
| Report Source | DISTRIBUTOR |
| Date Received | 2013-07-19 |
| Date of Report | 2013-07-18 |
| Date Mfgr Received | 2013-06-29 |
| 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 LANE |
| 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 | WHEELCHAIR ACCESSORY |
| Generic Name | WHEELCHAIR ACCESSORY |
| Product Code | KNO |
| Date Received | 2013-07-19 |
| Model Number | 7740P |
| 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 | 2013-07-19 |