MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-08-05 for COLD KNIFE (HALF MOON) K-HM manufactured by Acmi Stamford.
[17903032]
"the knife tip has broken twice inside the patient while in use. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218764-2002-00018 |
| MDR Report Key | 409939 |
| Report Source | 06 |
| Date Received | 2002-08-05 |
| Date of Report | 2002-08-05 |
| Date of Event | 2002-05-29 |
| Date Facility Aware | 2002-05-29 |
| Date Mfgr Received | 2002-07-02 |
| Date Added to Maude | 2002-08-14 |
| 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 | 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 | 0588042708 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLD KNIFE (HALF MOON) |
| Generic Name | EZO |
| Product Code | EZO |
| Date Received | 2002-08-05 |
| Model Number | K-HM |
| Catalog Number | K-HM |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 398952 |
| Manufacturer | ACMI STAMFORD |
| Manufacturer Address | 300 STILLWATER AVENUE STAMFORD CT 06904 US |
| Baseline Brand Name | COLD KNIFE (HALF MOON) |
| Baseline Generic Name | EXO |
| Baseline Model No | K-HM |
| Baseline Catalog No | K-HM |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-08-05 |