MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2000-02-29 for UNIVERSAL ACTIVE CORD SN-UAC manufactured by Circon Acmi.
[192949]
Cord returned to mfr with a complaint that it came apart while in use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2000-00010 |
| MDR Report Key | 266675 |
| Report Source | 06 |
| Date Received | 2000-02-29 |
| Date of Report | 2000-02-29 |
| Date Mfgr Received | 2000-02-14 |
| Date Added to Maude | 2000-03-06 |
| 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 | RONALD EHMSEN, SC.D. |
| Manufacturer Street | 6500 HOLLISTER AVE |
| Manufacturer City | SANTA BARBARA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | 8059613290 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL ACTIVE CORD |
| Generic Name | ACTIVE CORD |
| Product Code | FFZ |
| Date Received | 2000-02-29 |
| Returned To Mfg | 2000-02-14 |
| Model Number | SN-UAC |
| Catalog Number | SN-UAC |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 258162 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 448570409 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-02-29 |