MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-17 for * 40918 manufactured by Invacare Corporation.
[3316178]
Patient called stating the cane collapsed on her when she was walking on her porch. This caused the patient to injure her knee and break a couple of her false teeth. Patient requested call back. Medequip was notified of situation and is trying to make contact with patient for follow-up. Patient's cane #40918 was recalled and invacare mailed a new cane to patient's home address. It is unknown at this time if the cane was the replacement cane that invacare sent or the recalled cane that was dispensed in june 2012. Patient also received an hd cane in june 2009. What was the original intended procedure? Cane for walking stability.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3019642 |
| MDR Report Key | 3019642 |
| Date Received | 2013-03-17 |
| Date of Report | 2013-03-11 |
| Date of Event | 2012-12-28 |
| Report Date | 2013-03-11 |
| Date Reported to FDA | 2013-03-17 |
| Date Reported to Mfgr | 2013-03-25 |
| Date Added to Maude | 2013-03-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | CANE, SAFETY WALK |
| Product Code | KHY |
| Date Received | 2013-03-17 |
| Model Number | 40918 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE CORPORATION |
| Manufacturer Address | 1 INVACARE WAY ELYRIA OH 44035 US 44035 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-17 |