MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-09-26 for GYNESYS CERVICAL ACCESS CATHETER GSC100 manufactured by B Braun Medical Inc..
[21615038]
It was reported that during a hysterosalpingogram, the balloon would not inflate and the tip had broken off and became lodged in the cervical canal. The pt could not tolerate manipulation to retrieve it. The physician has scheduled a d&c to remove it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2003-00386 |
| MDR Report Key | 485642 |
| Report Source | 05,06 |
| Date Received | 2003-09-26 |
| Date of Report | 2003-08-29 |
| Date of Event | 2003-08-29 |
| Date Facility Aware | 2003-08-29 |
| Report Date | 2003-08-29 |
| Date Mfgr Received | 2003-08-29 |
| Date Added to Maude | 2003-10-01 |
| 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. MARK YALE |
| Manufacturer Street | ROUTE 22 WEST P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182326 |
| Manufacturer G1 | B BRAUN MEDICAL INC. |
| Manufacturer Street | 18 OLNEY AVE BLDG. #44 |
| Manufacturer City | CHERRY HILL NJ 08003 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08003 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNESYS CERVICAL ACCESS CATHETER |
| Generic Name | CATHETER |
| Product Code | HDY |
| Date Received | 2003-09-26 |
| Model Number | NA |
| Catalog Number | GSC100 |
| Lot Number | 0060005132 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 474527 |
| Manufacturer | B BRAUN MEDICAL INC. |
| Manufacturer Address | 18 OLNEY AVE BLDG. #44 CHERRY HILL NJ 08003 US |
| Baseline Brand Name | CYNESYS CERVICAL ACCESS CATHETER |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | GSC100 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-09-26 |