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 2004-05-06 for DISPOSABLE CABLE DAC manufactured by Acmi Norwalk.
[314549]
During the procedure, the dr saw an electrical arc to pt. There is no report of pt or practitioner injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2004-00034 |
| MDR Report Key | 558892 |
| Report Source | 05,06,07 |
| Date Received | 2004-05-06 |
| Date of Report | 2004-05-05 |
| Date of Event | 2004-03-26 |
| Date Facility Aware | 2004-04-06 |
| Report Date | 2004-05-05 |
| Date Mfgr Received | 2004-04-06 |
| Date Added to Maude | 2004-12-13 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN RING, JR |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 017722104 |
| Manufacturer Country | US |
| Manufacturer Postal | 017722104 |
| Manufacturer Phone | 5088042697 |
| Manufacturer G1 | ACMI NORWALK |
| Manufacturer Street | 93 NORTH PLEASANT STREET |
| Manufacturer City | NORWALK OH 44857040 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44857 0409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE CABLE |
| Generic Name | ELECTRICAL CORD |
| Product Code | FFZ |
| Date Received | 2004-05-06 |
| Model Number | DAC |
| Catalog Number | DAC |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 548587 |
| Manufacturer | ACMI NORWALK |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 448570409 US |
| Baseline Brand Name | DISPOSABLE ACTIVE CORD |
| Baseline Generic Name | ACTIVE CORD |
| Baseline Model No | DAC |
| Baseline Catalog No | DAC |
| Baseline ID | NA |
| Baseline Device Family | ACTIVE CORD |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-05-06 |