MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-18 for KH 1000 INTEGRATED LEEP GENERATOR KH1000 6098 manufactured by Cooper Surgical.
[1451474]
A female pt underwent outpatient leep procedure under general anesthesia in hospital or. During procedure, grounding pad came off 80%. Rn put grounding pad back on. Pt sustained a third degree burn on her lateral thigh. Leep device did not have an alarm or shut off feature for when pad became dislodged. Dates of use: 2008 - 2009. Diagnosis or reason for use: cervical dysplasia. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014050 |
| MDR Report Key | 1564738 |
| Date Received | 2009-12-18 |
| Date of Report | 2009-12-18 |
| Date of Event | 2009-12-11 |
| Date Added to Maude | 2009-12-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KH 1000 INTEGRATED LEEP GENERATOR |
| Generic Name | LEEP GENERATOR |
| Product Code | ODR |
| Date Received | 2009-12-18 |
| Model Number | KH1000 |
| Catalog Number | 6098 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2009-12-18 |