MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-23 for GOLDSTEIN SONOHYSTEROGRAPHY CATH J-GSHC-522620 G18664 manufactured by Cook Medical.
[68519377]
Pt called physician to report a retained foreign object. The pt stated something was left inside her after a saline sonogram was performed and that it had come out of her vagina later the same day. A cook medical goldstein sonohysterography catheter was used. The pt described the item as a small white cylindrical tube approx 1 inch long. The pt brought the item into the physician office and it was identified by the physician as a plastic tip of the goldstein sonohysterography catheter. The physician was unaware the tip is actually a separate piece from the catheter and that it can come off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068137 |
| MDR Report Key | 6360770 |
| Date Received | 2017-02-23 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-01-25 |
| Date Added to Maude | 2017-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GOLDSTEIN SONOHYSTEROGRAPHY CATH |
| Generic Name | CATHETER |
| Product Code | HFF |
| Date Received | 2017-02-23 |
| Model Number | J-GSHC-522620 |
| Catalog Number | G18664 |
| Lot Number | 7396664 |
| Device Expiration Date | 2019-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-23 |