MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-18 for THE KOH COLPOTOMIZER SYSTEM manufactured by Cooper Medical.
[16187970]
Pt complained of foul smelling vaginal discharge 4 months post robotic assisted laparoscopic supracervical hysterectomy. The rumi system and colpopneumo occluder system was used and the plastic koh cup was retained in vagina. The koh cup was removed in the clinic at the time of discovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037350 |
| MDR Report Key | 3952631 |
| Date Received | 2014-07-18 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-06-28 |
| Date Added to Maude | 2014-07-24 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | THE KOH COLPOTOMIZER SYSTEM |
| Generic Name | COLPOTOMIZER SYSTEM |
| Product Code | HEX |
| Date Received | 2014-07-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER MEDICAL |
| Manufacturer Address | TRUMBULL 06611 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-18 |