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 2020-01-27 for COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER G17870 J-CHSG-703000 manufactured by Cook Inc.
[177399120]
(b)(6). Occupation: manager of diagnostic imaging. 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
[177399121]
It was reported, prior to an xray hysterosalpingogram using a cook silicone balloon hysterosalpingography (hsg) injection catheter, the device would not deflate. The physician tested the device prior to use on the patient by inflating with 1. 5ml of air, but it failed to deflate. Another same type hsg device was tested and used to complete the procedure. No adverse effects were reported due to the alleged malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2020-00207 |
| MDR Report Key | 9631285 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-27 |
| Date of Report | 2020-02-17 |
| Date of Event | 2020-01-17 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-07-12 |
| Date Added to Maude | 2020-01-27 |
| 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 | UNK JENNIFER CANADA |
| 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 | 2020-01-27 |
| Returned To Mfg | 2020-02-10 |
| Model Number | G17870 |
| Catalog Number | J-CHSG-703000 |
| Lot Number | 9877203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-27 |