MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-12 for KC-RUMI-30 manufactured by Coopersurgical, Inc..
[123684611]
Coopersurgical inc. Is currently investigating the reported complaint condition. The actual device involved in the complaint has been returned for evaluation by the customer. Once the investigation is completed a follow-up report will be filled. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[123684612]
Doctor "tested the "donut" outside of the patient and it was fine. Began to use it inside the patient, and only once it was fully inflated did it start to leak - springing out like a fountain onto the operating room fellow. " increased length of surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00057 |
| MDR Report Key | 7960659 |
| Date Received | 2018-10-12 |
| Date of Report | 2018-10-12 |
| Date of Event | 2018-07-31 |
| Date Mfgr Received | 2018-09-20 |
| Device Manufacturer Date | 2018-03-23 |
| Date Added to Maude | 2018-10-12 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| 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 | KC-RUMI-30 |
| Generic Name | KC-RUMI-30 |
| Product Code | HEW |
| Date Received | 2018-10-12 |
| Returned To Mfg | 2018-09-20 |
| Model Number | KC-RUMI-30 |
| Catalog Number | KC-RUMI-30 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-10-12 |