MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99,unknown,user facility report with the FDA on 2015-03-17 for E-THOTIC manufactured by Fixes 4 Kids.
[20019698]
Customer is complaining that they are following the manufacturer's recommendations on adjusting the tension of the e-thotic; however, based upon their last two patients they are finding the device is difficult to adjust and are having to remove the brace earlier than required. As such, the key surgeon for this device has stated, "i am holding off on further use for now". Additionally, the customer is returning all unused e-thotics, pin guides, pin guide holder and fixture (101,103, 201,202, & 203). The surgeon is stating, "my last two patients ended up in the er with swelling that required removing the e-thotic early. "
Patient Sequence No: 1, Text Type: D, B5
[33719814]
Initial report was filed in error. Device is not imported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2921578-2015-00008 |
| MDR Report Key | 4664173 |
| Report Source | 99,UNKNOWN,USER FACILITY |
| Date Received | 2015-03-17 |
| Date of Report | 2015-03-11 |
| Date of Event | 2015-01-01 |
| Date Facility Aware | 2014-05-30 |
| Report Date | 2015-03-17 |
| Date Reported to Mfgr | 2015-03-17 |
| Date Added to Maude | 2015-04-08 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 | ANNE LEBLANC |
| Manufacturer Street | 30031 AHERN AV |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal | 945871234 |
| Manufacturer Phone | 5104291500 |
| Manufacturer G1 | MIZUHO ORTHOPEDIC SYSTEMS, INC. |
| Manufacturer Street | 30031 AHERN AVE. |
| Manufacturer City | UNION CITY CA 945871234 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 945871234 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-THOTIC |
| Generic Name | SPLINT, EXTREMITY, NON-INFLATABLE, EXTERNAL, NON-STERILE, PRODUCT CODE: NOC |
| Product Code | NOC |
| Date Received | 2015-03-17 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FIXES 4 KIDS |
| Manufacturer Address | 2200 15TH ST N WAHPETON ND 58075 US 58075 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-03-17 |