MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-13 for WHEELCHAIR ACCESSORY 9070 manufactured by H Fine And Son Ltd.
[63704344]
Per importer's mdr: mdr decision date: 01/10/2013. On 01/15/2013 - seh: no serious injury alleged. Malfunction alleged. The dealer stated the straps are ripping on one side. Mdr filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004859134-2013-00003 |
| MDR Report Key | 6206515 |
| Date Received | 2013-06-13 |
| Date of Report | 2013-06-13 |
| Date Mfgr Received | 2013-06-06 |
| Date Added to Maude | 2016-12-27 |
| 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 | H FINE AND SON LTD. |
| Manufacturer Street | 93 MANOR FARM RD. |
| Manufacturer City | WEMBLEY, MIDDLESEX HAO 1XB |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HAO 1XB |
| 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 | 2013-06-13 |
| Model Number | 9070 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | H FINE AND SON LTD |
| Manufacturer Address | 93 MANOR FARM RD. WEMBLEY, MIDDLESEX HAO 1XB UK HAO 1XB |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-13 |