MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2006-06-06 for COLD KNIFE (VUS-22) K-SB manufactured by Acmi Norwalk.
[493792]
Cold knife broke off in patient. Piece was retrieved from the patient three days later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2006-00002 |
| MDR Report Key | 725754 |
| Report Source | 06,07 |
| Date Received | 2006-06-06 |
| Date of Report | 2006-06-06 |
| Date of Event | 2006-04-25 |
| Date Facility Aware | 2006-05-08 |
| Date Mfgr Received | 2006-05-08 |
| Date Added to Maude | 2006-06-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | TERRENCE SULLIVAN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042739 |
| Manufacturer G1 | ACMI NORWALK |
| Manufacturer Street | 93 NORTH PLEASANT STREET |
| Manufacturer City | NORWALK OH 44857040 |
| Manufacturer Postal Code | 44857 0409 |
| Single Use | 3 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLD KNIFE (VUS-22) |
| Generic Name | 500 |
| Product Code | GDX |
| Date Received | 2006-06-06 |
| Model Number | K-SB |
| Catalog Number | K-SB |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DAY |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 715639 |
| Manufacturer | ACMI NORWALK |
| Manufacturer Address | NORWALK OH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-06 |