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 2019-03-04 for COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER J-CHSG-703001 manufactured by Cook Inc.
[138418253]
(b)(4). 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
[138418254]
It was reported on (b)(6) 2019, the cook silicone balloon hysterosalpingography injection catheter balloon was inflated to test it before usage in an hysterosalpingography (hsg) procedure but the balloon could not be deflated. After half an hour, the balloon deflated on its own. A different catheter was used to treat the patient that did deflate properly. There was no harm to the patient. Additional information provided on (b)(6) 2019. As reported the balloon was inflated to circa 3 ml with air using the provided syringe with no difficulty, but it would not deflate. We did not use this catheter; no patient contact. There was no leakage observed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00532 |
| MDR Report Key | 8387258 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-04 |
| Date of Report | 2019-04-18 |
| Date of Event | 2019-02-18 |
| Date Mfgr Received | 2019-03-22 |
| Device Manufacturer Date | 2018-11-01 |
| Date Added to Maude | 2019-03-04 |
| 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 | 2019-03-04 |
| Catalog Number | J-CHSG-703001 |
| Lot Number | 9279409 |
| 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 | 2019-03-04 |