MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-15 for KOH-EFFICIENT,RUMI,3.5CM KC-ARCH-35 manufactured by Coopersurgical, Inc..
[142198039]
Coopersurgical inc. Is currently investigating the reported complaint condition. Once the investigation is completed a follow-up report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[142198040]
"the case was going fine, they filled up the occluder balloon when they started the colpotomy, they got half way done with the colpotomy, and then there was a rapid loss of pneumo. They could hear the gas escaping through the vagina. They had to go below 4 different times, to pack the vagina with lap sponges, to try to keep pneumo, so they could successfully complete the colpotomy. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00046 |
| MDR Report Key | 8515406 |
| Date Received | 2019-04-15 |
| Date of Report | 2019-02-13 |
| Date of Event | 2019-01-16 |
| Device Manufacturer Date | 2018-05-22 |
| Date Added to Maude | 2019-04-15 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 50 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL DE 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | KOH-EFFICIENT,RUMI,3.5CM |
| Generic Name | KOH-EFFICIENT,RUMI,3.5CM |
| Product Code | HEW |
| Date Received | 2019-04-15 |
| Model Number | KC-ARCH-35 |
| Catalog Number | KC-ARCH-35 |
| Lot Number | 248120 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-15 |