MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-03-07 for HUGO 781-030 manufactured by Amg Medical Inc..
[69255240]
As the hugo brand is now owned by drive medical, they were the ones that were made aware of the incident. They received a lawyer's letter and forwarded it to a. M. G. Medical inc. On march 3, 2017. Little information on the previous health and condition of the customer is mentioned. The location of the incident is unknown. Our insurance company will be in contact with the patient's lawyer so that the missing information can be obtained.
Patient Sequence No: 1, Text Type: N, H10
[69255241]
Customer was using hugo quadpod cane when the handle suddenly slipped, causing him to fall and suffer injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022077-2017-00047 |
| MDR Report Key | 6383720 |
| Report Source | OTHER |
| Date Received | 2017-03-07 |
| Date of Report | 2017-03-07 |
| Date of Event | 2016-06-01 |
| Date Mfgr Received | 2017-03-03 |
| Date Added to Maude | 2017-03-07 |
| 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 | ATTORNEY |
| 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, QUEBEC H4T1V5 |
| Manufacturer Country | CA |
| Manufacturer Postal | H4T1V5 |
| Manufacturer Phone | 7375251 |
| 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 | 3 |
| Brand Name | HUGO |
| Generic Name | HUGO QUADPOD |
| Product Code | KHY |
| Date Received | 2017-03-07 |
| Model Number | 781-030 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2017-03-07 |