MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for DESIGNER QUAD CANE C-604S-CD04 W1303I manufactured by Homecare Enterprise Co. Ltd..
[134594971]
Per dealer, end user was using cane normally when shaft broke and end user fell. No injuries were reported. Dealer refused to give information on end user. Data for eu is approximate.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2019-00001 |
| MDR Report Key | 8292749 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2019-01-14 |
| Report Date | 2019-01-31 |
| Date Reported to FDA | 2019-01-31 |
| Date Reported to Mfgr | 2019-01-31 |
| Date Added to Maude | 2019-01-31 |
| 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 |
| 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 | 3 |
| Brand Name | DESIGNER QUAD CANE |
| Generic Name | QUAD CANE |
| Product Code | IPS |
| Date Received | 2019-01-31 |
| Model Number | C-604S-CD04 |
| Catalog Number | W1303I |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOMECARE ENTERPRISE CO. LTD. |
| Manufacturer Address | NO. 11 CHANGSHENG ST HUATAN TOWNSHIP CHANGHUA COUNTY, TAIWAN 50347 TW 50347 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-31 |