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 2019-01-29 for WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON J-BGC-015055 manufactured by Cook Inc.
[134315301]
(b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[134315302]
It was reported that during the course of treatment for bartholin gland abscess, the patient had a word catheter silicone bartholin gland balloon placed on (b)(6) 2018. The device placement location was unspecified. On (b)(6) 2019, 31 days after the device was placed, the device was removed by the physician. It is reported that when the physician proceeded to remove the device, the wound had closed. The physician had to make a new incision to access and remove the balloon. It is reported that the balloon was found deflated and having migrated into the cyst cavity. The patient's outcome post procedure is unknown at this time. Additional information has been requested regarding the original placement location of the device, as well as other pertinent details regarding the patient and the event. At the time of this report, no additional information has been provided. Precaution listed on the instructions for use (ifu): epithelization time may vary depending on each patient. The word catheter-silicone bartholin gland balloon is not intended to be left indwelling for periods of time greater than twenty-eight (28) days. Instructions for use include: clean area surrounding bartholin gland with appropriate antiseptic solution. Using enclosed scalpel, make an incision in the outer wall of the cyst, preferably inside the hymenal ring, to break up loculations. Once the abscess has been drained, insert deflated silicone catheter through the incision and into the cystic body. Using the enclosed syringe, carefully inflate the silicone catheter with sterile saline until the balloon is sufficiently retained in the cyst, not exceeding maximum inflation volume of the device (3ml). Once inflated, remove the syringe and needle, leaving the saline-inflated word catheter within the cystic mass. Tuck free end of the catheter up into the vagina.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2019-00206 |
| MDR Report Key | 8284530 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-29 |
| Date of Report | 2019-04-22 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-03-29 |
| Device Manufacturer Date | 2018-07-31 |
| Date Added to Maude | 2019-01-29 |
| 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 | 2019-01-29 |
| Catalog Number | J-BGC-015055 |
| Lot Number | 9056658 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2019-01-29 |