MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-28 for HUGO 781-030 manufactured by Amg Medical Inc..
[56349540]
We verified and tested our stock and did not see any cracks. We will monitor this closely but for now this is an isolated occurrence. The customer did not fall and there was no injury. This case is now closed.
Patient Sequence No: 1, Text Type: N, H10
[56349541]
Customer purchased 2 quad pods and they broke a few weeks later. We sent the customer new quad pod tips and the new ones also started to fail, one side is broken and is splitting away at the central shaft. The customer did not fall and there was no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022077-2016-00063 |
| MDR Report Key | 5984578 |
| Date Received | 2016-09-28 |
| Date of Report | 2016-09-28 |
| Date Mfgr Received | 2016-08-04 |
| Date Added to Maude | 2016-09-28 |
| 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 |
| 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, QUEBEC 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 | HUGO QUADPOD ULTRA STABLE CANE TIP |
| Product Code | INP |
| Date Received | 2016-09-28 |
| Model Number | 781-030 |
| 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, QUEBEC H4T1V5 CA H4T1V5 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-28 |