MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-28 for HUGO 731-859 manufactured by Amg Medical Inc..
[103777954]
We did not receive more information regarding the cane. We asked the customer to send us pictures of the broken cane but never received any pictures. An investigation could not be done on the unit since it was never sent to our head office. This is considered an isolated occurrence until we receive further information. A final report will be submitted once we receive more information.
Patient Sequence No: 1, Text Type: N, H10
[103777955]
The customer walked about 10 steps from her bedroom to her bathroom using the cane. In the bathroom, the cane snapped/broke and caused the customer to fall and hit her head knocking her unconscious. Some time later, she was found unconscious and taken to the hospital via ambulance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022077-2018-00110 |
| MDR Report Key | 7379500 |
| Date Received | 2018-03-28 |
| Date of Report | 2018-03-28 |
| Date of Event | 2016-05-06 |
| Date Mfgr Received | 2018-02-22 |
| Date Added to Maude | 2018-03-28 |
| 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 |
| Reporter Occupation | PATIENT FAMILY MEMBER OR FRIEND |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KATIA TOPALIAN |
| Manufacturer Street | 8505 DALTON |
| Manufacturer City | MONTREAL, H4T1V5 |
| Manufacturer Country | CA |
| Manufacturer Postal | H4T1V5 |
| Manufacturer G1 | AMG MEDICAL INC. |
| Manufacturer Street | 8505 DALTON |
| Manufacturer City | MONTREAL, H4T1V5 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | H4T1V5 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HUGO |
| Generic Name | AQUA OFFSET CANE |
| Product Code | KHY |
| Date Received | 2018-03-28 |
| Model Number | 731-859 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMG MEDICAL INC. |
| Manufacturer Address | 8505 DALTON MONTREAL, H4T1V5 CA H4T1V5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2018-03-28 |