MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-01-29 for BAKRI TAMPONADE BALLOON CATHETER J-SOS-100500 manufactured by Cook Inc.
[98646268]
This mdr is being filed after the associated complaint was reviewed under remediation protocol cap(b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[98646269]
The complainant reported that the balloon slipped out of the uterus multiple times. Saline leakage was noted during removal of the balloon and the customer suspected that the balloon burst during insertion. There no reported adverse effects to the patient as a result of the reported product problems.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00285 |
| MDR Report Key | 7224116 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-29 |
| Date of Report | 2018-01-29 |
| Date of Event | 2016-03-09 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2015-11-11 |
| Date Added to Maude | 2018-01-29 |
| 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. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAKRI TAMPONADE BALLOON CATHETER |
| Generic Name | KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC |
| Product Code | KNA |
| Date Received | 2018-01-29 |
| Catalog Number | J-SOS-100500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-29 |