MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-26 for KIT FF MALE PYRAMID CAT 7-9 FFC2210002 manufactured by Ossur Iceland.
[36896863]
Patient Sequence No: 1, Text Type: N, H10
[36896864]
Amputee patient states he fell while walking when bolts holding his adapter broke. The patient ripped his pants and fell on his shoulders while on the job. He said his shoulders were bothering him. Patient claims no injury but said he was going to see his doctor.
Patient Sequence No: 1, Text Type: D, B5
[45333377]
Patient Sequence No: 1, Text Type: N, H10
[45333378]
Amputee patient states he fell while walking when bolts holding his adapter broke. The patient ripped his pants and fell on his shoulders while on the job. He said his shoulders were bothering him. Patient claims no injury but said he was going to see his doctor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2016-00001 |
| MDR Report Key | 5391461 |
| Date Received | 2016-01-26 |
| Date of Report | 2016-01-26 |
| Date of Event | 2015-12-16 |
| Date Mfgr Received | 2015-12-16 |
| Date Added to Maude | 2016-01-26 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIT FF MALE PYRAMID CAT 7-9 |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2016-01-26 |
| Returned To Mfg | 2016-03-15 |
| Model Number | FFC2210002 |
| Catalog Number | FFC2210002 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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. Other | 2016-01-26 |