MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-12 for SURE GRIP ORTHO CANE RPM79030-BRZ W1448BR manufactured by R. Poon Medical Products Company Ltd.
[113875134]
Home medical equipment dealer refused information regarding patient based on her understanding of hippa.
Patient Sequence No: 1, Text Type: N, H10
[113875135]
End user was walking with a cane when the shaft snapped. There was no fall or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2018-00002 |
| MDR Report Key | 7682263 |
| Date Received | 2018-07-12 |
| Date of Report | 2018-06-19 |
| Date of Event | 2018-06-19 |
| Date Facility Aware | 2018-06-19 |
| Report Date | 2018-07-12 |
| Date Reported to FDA | 2018-07-12 |
| Date Reported to Mfgr | 2018-07-12 |
| Date Added to Maude | 2018-07-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SURE GRIP ORTHO CANE |
| Generic Name | CANE |
| Product Code | IPS |
| Date Received | 2018-07-12 |
| Model Number | RPM79030-BRZ |
| Catalog Number | W1448BR |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | R. POON MEDICAL PRODUCTS COMPANY LTD |
| Manufacturer Address | NO. 116 QICANG ROAD MINGGUANG, ANHUI 239400 CH 239400 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-12 |