MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-21 for ICEROSS COMFORT 36 I-540636 I-540635 manufactured by Ossur Iceland.
[60622544]
Limited information provided to us through attorney. No details related to claim of 'significant injuries to his right leg and other portions of his body'.
Patient Sequence No: 1, Text Type: N, H10
[60622545]
Amputee patient walking down the hall at home and fell. There is a claim of significant injuries to his right let and other portions of his body. The user took the prosthetic to the local cpo who resolved the issue. Therapist claims the pin worked its way out of the sleeve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2016-00009 |
| MDR Report Key | 6118986 |
| Date Received | 2016-11-21 |
| Date of Report | 2016-11-21 |
| Date of Event | 2015-12-13 |
| Date Mfgr Received | 2016-11-10 |
| Date Added to Maude | 2016-11-21 |
| 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 | 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 ICELAND |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK, 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ICEROSS COMFORT 36 |
| Generic Name | COMPONENT, EXTERNAL LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2016-11-21 |
| Model Number | I-540636 |
| Catalog Number | I-540635 |
| Lot Number | 441 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-11-21 |