MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-18 for ADULT COLD KNIFE (3 PER PACK) G500 manufactured by Acmi Norwalk.
[18328198]
Two knives broke, inside a patient. The patient was not injured and the knives were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2002-00075 |
| MDR Report Key | 434654 |
| Date Received | 2002-12-18 |
| Date of Report | 2002-12-11 |
| Date of Event | 2002-11-12 |
| Date Facility Aware | 2002-11-12 |
| Date Added to Maude | 2002-12-31 |
| 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 | 3 |
| Manufacturer Contact | DON KEREN |
| Manufacturer Street | 136 TURNPIKE RD |
| Manufacturer City | SOUTHBOROUGH MA 01772 |
| Manufacturer Country | US |
| Manufacturer Postal | 01772 |
| Manufacturer Phone | 5088042708 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT COLD KNIFE (3 PER PACK) |
| Generic Name | EZO |
| Product Code | EZO |
| Date Received | 2002-12-18 |
| Model Number | G500 |
| Catalog Number | G500 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 423605 |
| Manufacturer | ACMI NORWALK |
| Manufacturer Address | 93 NORTH PLEASANT STREET NORWALK OH 448570409 US |
| Baseline Brand Name | CLASSIC SERIES URETHROTOME COLD KNIFE |
| Baseline Generic Name | URETHROTOME |
| Baseline Model No | G501 |
| Baseline Catalog No | G501 |
| Baseline ID | NA |
| Baseline Device Family | COLD KNIFE |
| 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 | 2002-12-18 |