MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-08-12 for CALF IMPLANT CCB2-3 manufactured by Hanson Medical.
[1590826]
Abscess of left calf implant.
Patient Sequence No: 1, Text Type: D, B5
[8773561]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2031444-2008-00001 |
| MDR Report Key | 1811611 |
| Report Source | 07 |
| Date Received | 2010-08-12 |
| Date of Report | 2008-05-07 |
| Date of Event | 2007-12-07 |
| Date Facility Aware | 2007-12-07 |
| Report Date | 2008-05-07 |
| Date Reported to FDA | 2008-05-07 |
| Date Reported to Mfgr | 2008-05-07 |
| Date Mfgr Received | 2008-06-08 |
| Device Manufacturer Date | 2002-11-01 |
| Date Added to Maude | 2010-10-27 |
| 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 | GERALD HANSON |
| Manufacturer Street | 825 RIVERSIDE S #2 |
| Manufacturer City | PASO ROBLES CA 93446 |
| Manufacturer Country | US |
| Manufacturer Postal | 93446 |
| Manufacturer Phone | 3602971997 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CALF IMPLANT |
| Generic Name | IMPLANT |
| Product Code | MIB |
| Date Received | 2010-08-12 |
| Model Number | NA |
| Catalog Number | CCB2-3 |
| Lot Number | 4028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANSON MEDICAL |
| Manufacturer Address | 308 NORTH BERNARDO AVE MOUNTAIN VIEW CA 94043 US 94043 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-08-12 |