MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-06 for COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER J-CHSG-503000 manufactured by Cook Inc.
[130052775]
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
[130052776]
The complainant reported that during the preparation for the saline sonohystogram procedure, the silicone hysterosalpingography injection catheter balloon would only half inflate and would not deflate. Another device was used to complete the procedure. There were no adverse effects reported due to the event and no report of an additional procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03650 |
| MDR Report Key | 8138630 |
| Date Received | 2018-12-06 |
| Date of Report | 2018-12-06 |
| Date Mfgr Received | 2018-11-29 |
| Device Manufacturer Date | 2016-05-13 |
| Date Added to Maude | 2018-12-06 |
| 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 |
| 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 | 0 |
| Brand Name | COOK SILICONE BALLOON HYSTEROSALPINGOGRAPHY INJECTION CATHETER |
| Generic Name | HES INSUFFLATOR-CARBON DIOXIDE, URETOTUBAL (AND ACCESSORIES) |
| Product Code | HES |
| Date Received | 2018-12-06 |
| Returned To Mfg | 2016-10-13 |
| Model Number | NA |
| Catalog Number | J-CHSG-503000 |
| Lot Number | 6970369 |
| Device Expiration Date | 2019-05-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-12-06 |