MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-01-12 for SHOE DH OFFLOAD MD 10341 manufactured by Ossur Americas.
[64654244]
Fda medwatch report received indicating: the top cap seam caused abrasive pressure resulting in a blister. The patient visited the doctor and medications were provided to treat the ulcer but eventual amputation of the 5th metatarsal and 5th toe was needed. There was no indication of the original fitting fo the dh offloading shoe.
Patient Sequence No: 1, Text Type: D, B5
[70567933]
Patient Sequence No: 1, Text Type: N, H10
[70567935]
Fda medwatch report received indicating: the top cap seam caused abrasive pressure resulting in a blister. The patient visited the doctor and medications were provided to treat the ulcer but eventual amputation of the 5th metatarsal and 5th toe was needed. There was no indication of the original fitting fo the dh offloading shoe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2017-00001 |
| MDR Report Key | 6245849 |
| Report Source | OTHER |
| Date Received | 2017-01-12 |
| Date of Report | 2017-03-09 |
| Date of Event | 2016-11-09 |
| Date Mfgr Received | 2016-12-20 |
| Date Added to Maude | 2017-01-12 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 | 9492757557 |
| 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 | SHOE DH OFFLOAD MD |
| Generic Name | SHOE CAST |
| Product Code | IPG |
| Date Received | 2017-01-12 |
| Model Number | 10341 |
| Catalog Number | 10341 |
| 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. Required No Informationntervention | 2017-01-12 |