MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-01-06 for FOOT UP 27810-2 manufactured by Ossur Americas.
[35187748]
Aktiv ortopedteknick stated they are uncertain that this claim of injury is related to the product since the damage was on the toe and the product is used on the ankle. We are working to obtain further information from the clinic and patient.
Patient Sequence No: 1, Text Type: N, H10
[35187749]
Very little information was provided by the customer. We are working with them to obtain more information. The claim is the patient had a toe amputated due to pressure sores.
Patient Sequence No: 1, Text Type: D, B5
[39887234]
(b)(4) stated they are uncertain that this claim of injury is related to the product since the damage was on the toe and the product is used on the ankle. We are working to obtain further information from the clinic and patient.
Patient Sequence No: 1, Text Type: N, H10
[39887235]
Very little information was provided by the customer. We are working with them to obtain more information. The claim is the patient had a toe amputated due to pressure sores.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2016-00001 |
| MDR Report Key | 5348122 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-01-06 |
| Date of Report | 2016-01-06 |
| Date of Event | 2015-11-23 |
| Date Mfgr Received | 2015-12-18 |
| Date Added to Maude | 2016-01-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. KAREN MONTES |
| Manufacturer Street | 27051 TOWNE CENTRE DRIVE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9493823741 |
| Manufacturer G1 | OSSUR AMERICAS |
| Manufacturer Street | 27051 TOWNE CENTRE |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92610 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FOOT UP |
| Generic Name | ORTHOSIS |
| Product Code | KNP |
| Date Received | 2016-01-06 |
| Model Number | 27810-2 |
| Catalog Number | 27810-2 |
| Lot Number | EN090706 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR AMERICAS |
| Manufacturer Address | 27051 TOWNE CENTRE FOOTHILL RANCH CA 92610 US 92610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-01-06 |