MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-05-04 for FREEHAND SYSTEM UNK NA manufactured by Neurocontrol Corp.
[17906236]
Upon removal of cast after freehand system implantation, pt had discoloration in their arm. As a precaution, the pt was treated with antibiotics. Four days later, the physician reports that the pt had developed an infection at the area where the triceps transfer sutures are located. Pt had developed mrsa septicemia and infection and is treated with tx vancomycin for 2-6 weeks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00014 |
| MDR Report Key | 330184 |
| Report Source | 05,06,07 |
| Date Received | 2001-05-04 |
| Date of Report | 2001-04-04 |
| Date of Event | 2001-04-04 |
| Date Mfgr Received | 2001-04-04 |
| Date Added to Maude | 2001-05-07 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PAMELA THOMAS |
| Manufacturer Street | 8333 ROCKSIDE ROAD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal | 44125 |
| Manufacturer Phone | 2169120101 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2001-05-04 |
| Model Number | UNK |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 319549 |
| Manufacturer | NEUROCONTROL CORP |
| Manufacturer Address | 8333 ROCKSIDE RD VALLEY VIEW OH 441256104 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-05-04 |