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 2019-07-29 for WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON G55442 J-BGC-015055 manufactured by Cook Inc.
| Report Number | 1820334-2019-01833 |
| MDR Report Key | 8837981 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-29 |
| Date of Report | 2019-09-25 |
| Date of Event | 2019-07-23 |
| Date Mfgr Received | 2019-09-25 |
| Device Manufacturer Date | 2018-10-26 |
| Date Added to Maude | 2019-07-29 |
| 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 | WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON |
| Generic Name | KNA INSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC |
| Product Code | KNA |
| Date Received | 2019-07-29 |
| Returned To Mfg | 2019-09-12 |
| Model Number | G55442 |
| Catalog Number | J-BGC-015055 |
| Lot Number | 9263238 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-07-29 |