MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2010-11-26 for GOLDSTEIN SONOHYSTEROGRAPHY CATHETER J-GSHC-532600 manufactured by Cook Ob/gyn.
[20093659]
On (b)(6) 2010, pt presented for "saline infusion sonohysterography" for evaluation of infertility utilizing the listed product. On (b)(6) 2010, the pt checked the position of her cervix and noticed a "hard object" at the cervical entrance. She removed the object, placed it in a (b)(4) bag and reported to the er for evaluation. The piece appears to be an "adjustable acorn positioner" that holds the catheter in place and prevents leakage. The original item is not available, but another unused item from the same lot is available for evaluation. The pt suffered no adverse outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2594645 |
| MDR Report Key | 2594645 |
| Report Source | 99 |
| Date Received | 2010-11-26 |
| Date of Report | 2010-10-06 |
| Date of Event | 2010-09-23 |
| Date Facility Aware | 2010-10-05 |
| Report Date | 2010-10-06 |
| Date Added to Maude | 2012-06-05 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GOLDSTEIN SONOHYSTEROGRAPHY CATHETER |
| Generic Name | SONOHYSTEROGRAPHY CATHETER |
| Product Code | HFF |
| Date Received | 2010-11-26 |
| Model Number | J-GSHC-532600 |
| Lot Number | U1957881 |
| Device Expiration Date | 2013-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 3 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK OB/GYN |
| Manufacturer Address | SPENCER IN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-11-26 |