MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2006-10-17 for CAUTERY UNIT CGI-4000 63079 manufactured by Pentax Medical Co..
[3159219]
Patient underwent a colonoscopy. After procedure was completed patient was admitted to the emergency room for severe pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2941015 |
| MDR Report Key | 2941015 |
| Report Source | 99 |
| Date Received | 2006-10-17 |
| Date of Report | 2006-10-10 |
| Date of Event | 2006-06-21 |
| Date Facility Aware | 2006-06-21 |
| Report Date | 2006-10-10 |
| Date Reported to FDA | 2006-10-10 |
| Date Reported to Mfgr | 2006-10-10 |
| Date Added to Maude | 2013-02-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAUTERY UNIT |
| Generic Name | NONE |
| Product Code | HAM |
| Date Received | 2006-10-17 |
| Model Number | CGI-4000 |
| Catalog Number | 63079 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PENTAX MEDICAL CO. |
| Manufacturer Address | 102 CHESTNUT RIDGE ROAD MONTVALE NJ 07645 US 07645 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-10-17 |