MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-15 for KOH-EFFICIENT,RUMI,3.0CM KC-RUMI-30 manufactured by Coopersurgical, Inc..
[86598611]
Coopersurgical inc. Is currently investigating the reported complaint condition. Once the investigation is complaete a follow up report will be filed. Ref: e-complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86598612]
Reference e-complaint (b)(4). Uf/importer report # (b)(4). "surgeon was placing intrauterine tip in preparation for laparoscopic hysterectomy. Surgeon attempted to fill balloon for appropriate placement but balloon failed after filling less then 30ml saline and would not inflate. Placement of manipulator failed and a new tip was used. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2017-00061 |
| MDR Report Key | 6868809 |
| Date Received | 2017-09-15 |
| Date of Report | 2017-11-06 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-09-08 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2017-09-15 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 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,3.0CM |
| Generic Name | KOH-EFFICIENT,RUMI,3.0CM |
| Product Code | HEW |
| Date Received | 2017-09-15 |
| Returned To Mfg | 2017-09-29 |
| Model Number | KC-RUMI-30 |
| Catalog Number | KC-RUMI-30 |
| Lot Number | 204941 |
| Device Expiration Date | 2019-04-20 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-15 |