MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-25 for COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS J-SOSR-100500 manufactured by Cook Inc.
[98565694]
This medwatch is related to medwatch report number 1820334-2016-00566. This mdr is being filed after the associated complaint was reviewed under remediation protocol (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
[98565695]
The complainant reported that the balloon was placed and at this time the facility noted that the device only had a 2-way valve, when in fact it should have had a 3-way valve. The patient reportedly did not experience adverse effects as a result of the product problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00258 |
| MDR Report Key | 7218480 |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-25 |
| Date of Event | 2016-06-02 |
| Date Mfgr Received | 2018-01-22 |
| Device Manufacturer Date | 2015-12-04 |
| Date Added to Maude | 2018-01-25 |
| 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. 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 | 0 |
| Brand Name | COOK BAKRI POSTPARTUM BALLOON WITH RAPID INSTILLATION COMPONENTS |
| Generic Name | KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC |
| Product Code | KNA |
| Date Received | 2018-01-25 |
| Catalog Number | J-SOSR-100500 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2018-01-25 |