MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-20 for TALUX PYRAMID C6 27CM RIGHT TLP0627R manufactured by Ossur H/f.
[73333037]
Amputee (b)(6) year old patient walks with a cane, while walking, claims the foot broke just below the pyramid causing the patient to fall. The patient sought medical treatment and sustained a broken hip which required surgery. Patient is expected to make a full recovery.
Patient Sequence No: 1, Text Type: D, B5
[134443916]
Patient Sequence No: 1, Text Type: N, H10
[134443917]
Amputee (b)(6) year old patient walks with a cane, while walking, claims the foot broke just below the pyramid causing the patient to fall. The patient sought medical treatment and sustained a broken hip which required surgery. Patient is expected to make a full recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003764610-2017-00002 |
| MDR Report Key | 6509127 |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-04-02 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-04-20 |
| 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 |
| Manufacturer City | FOOTHILL RANCH CA 92610 |
| Manufacturer Country | US |
| Manufacturer Postal | 92610 |
| Manufacturer Phone | 9492757557 |
| Manufacturer G1 | OSSUR H/F |
| 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 | TALUX PYRAMID C6 27CM RIGHT |
| Generic Name | COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT |
| Product Code | ISH |
| Date Received | 2017-04-20 |
| Model Number | TLP0627R |
| Catalog Number | TLP0627R |
| 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 H/F |
| Manufacturer Address | GRJOTHALS 5 REYKJAVIK, 110 IC 110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-04-20 |