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 2019-05-21 for COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER G17870 J-CHSG-703000 manufactured by Cook Inc.
[145639022]
This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[145639023]
It is reported during a sonohysterosalpingography, in vagina cervix and uterus using a cook silicone balloon hysterosalpingography injection catheter, the balloon was impossible to deflate when the procedure was over. It is unknown how the procedure was completed after this issue was experienced. There were no adverse effects to the patient as a result of this alleged product malfunction. No section of the device remained inside the patient's body. The patient did not require any additional procedures as a result of this occurrence. Additional details regarding the patient and the event have been requested. At this time, no additional information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-01163 |
| MDR Report Key | 8627710 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-21 |
| Date of Report | 2019-07-03 |
| Date of Event | 2019-05-02 |
| Date Mfgr Received | 2019-06-07 |
| Device Manufacturer Date | 2018-01-26 |
| Date Added to Maude | 2019-05-21 |
| 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 | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER |
| Generic Name | HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES) |
| Product Code | HES |
| Date Received | 2019-05-21 |
| Model Number | G17870 |
| Catalog Number | J-CHSG-703000 |
| Lot Number | 8539787 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2019-05-21 |