MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-30 for DEMI FOLDING CANE B012-606S-109S-S W1351W manufactured by Homecare Enterprise Co. Ltd..
[129348451]
Shaft broke. There is no fall or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056127-2018-00005 |
| MDR Report Key | 8119828 |
| Date Received | 2018-11-30 |
| Date of Report | 2018-11-28 |
| Date of Event | 2018-10-24 |
| Date Facility Aware | 2018-11-02 |
| Report Date | 2018-11-30 |
| Date Reported to FDA | 2018-11-30 |
| Date Reported to Mfgr | 2018-11-28 |
| Date Added to Maude | 2018-11-30 |
| 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 | 0 |
| Brand Name | DEMI FOLDING CANE |
| Generic Name | FOLDING CANE |
| Product Code | IPS |
| Date Received | 2018-11-30 |
| Model Number | B012-606S-109S-S |
| Catalog Number | W1351W |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOMECARE ENTERPRISE CO. LTD. |
| Manufacturer Address | NO. 488, LUNMEI ROAD. CHANGHUA CITY, CHANGHUA 50071 TW 50071 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-30 |