MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-08-04 for ADULT COLD KNIFE (3 PER PACK) G500 manufactured by Acmi Norwalk.
[20508349]
Cold knife broke during procedure. The piece was not able to be retrieved at the present time. The patient is satisfactory with no injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2003-00028 |
| MDR Report Key | 476521 |
| Report Source | 05,06 |
| Date Received | 2003-08-04 |
| Date of Report | 2003-07-31 |
| Date of Event | 2003-06-02 |
| Date Facility Aware | 2003-06-02 |
| Report Date | 2003-07-31 |
| Date Mfgr Received | 2003-06-02 |
| Date Added to Maude | 2003-08-11 |
| 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 | JOHN RINGS, JR. |
| Manufacturer Street | 136 TURNPIKE ROAD |
| 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 | ADULT COLD KNIFE (3 PER PACK) |
| Generic Name | URETHROTOME ACCESSORY |
| Product Code | EZO |
| Date Received | 2003-08-04 |
| Model Number | G500 |
| Catalog Number | G500 |
| 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 | 465349 |
| Manufacturer | ACMI NORWALK |
| Manufacturer Address | 93 NORTH PLEASANT ST. 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 | 2003-08-04 |