MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-11-18 for FORM FIT NIGHT SPLINT 50033 manufactured by Ossur Americas.
[60360708]
Patient received a form fit night splint brace for use post-operative from hip labral repair. Patient had a stage 1 pressure ulcer on her heel after the 2nd day wearing the splint.
Patient Sequence No: 1, Text Type: D, B5
[61796069]
Patient Sequence No: 1, Text Type: N, H10
[61796070]
Patient received a form fit night splint brace for use post-operative from hip labral repair. Patient had a stage 1 pressure ulcer on her heel after the 2nd day wearing the splint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2085446-2016-00007 |
| MDR Report Key | 6112841 |
| Report Source | CONSUMER |
| Date Received | 2016-11-18 |
| Date of Report | 2016-12-08 |
| Date of Event | 2016-10-22 |
| Date Mfgr Received | 2016-10-28 |
| Date Added to Maude | 2016-11-18 |
| 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 | PATIENT |
| 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 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 | FORM FIT NIGHT SPLINT |
| Generic Name | JOINT, ANKLE, EXTERNAL BRACE |
| Product Code | ITW |
| Date Received | 2016-11-18 |
| Model Number | 50033 |
| Catalog Number | 50033 |
| 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. Other; 2. Required No Informationntervention | 2016-11-18 |