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 2015-10-26 for ASSURE EVO PYR CAT 4 S 28L FAPE428L manufactured by Ossur Iceland.
[29249335]
Patient weight indicates he is too heavy for the category 4 foot and should have been placed in a category 5 foot by the health professional. The female ortimex mating adapter is not compatible with the ossur male foot adapter used. We sent out a safety alert reminding customers to only use ossur adapters per the ifu.
Patient Sequence No: 1, Text Type: N, H10
[29249336]
Below knee amputee patient fell while walking causing broken shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2015-00012 |
| MDR Report Key | 5178028 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2015-10-26 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-06-09 |
| Date Mfgr Received | 2015-09-17 |
| Date Added to Maude | 2015-10-26 |
| 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 ICELAND |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASSURE EVO PYR CAT 4 S 28L |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2015-10-26 |
| Returned To Mfg | 2015-09-18 |
| Model Number | FAPE428L |
| Catalog Number | FAPE428L |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR ICELAND |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-10-26 |