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 2018-09-20 for WORD CATHETER SILICONE BARTHOLIN GLAND BALLOON J-BGC-015055 manufactured by Cook Inc.
[120893861]
(b)(6). Patient code: necrosis not labeled, infection not labeled. Device code: adverse event without identified device or use problem (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
[120893862]
It was reported a j-bgc-015055 was placed in an abscess of one of the bartholin? S glands on a patient on (b)(6). The doctor who placed the catheter flushed the cavity with saline before placement to make sure all pus was removed. Five days later, the patient came back with necrosis and infection around the catheter. The catheter was removed and the patient was given pain killers and antibiotics, but no other procedures besides that. It? S unclear if the product was the cause of this necrosis/infection. Update: after following up, additional information was received on 20sep2018. The patient doesn? T smoke and is overall healthy. The area was cleaned and the scalpel was used to puncture the abscess. The abscess was drained and the cavity was flushed with saline to make sure all pus was removed. Then the catheter was inserted and filled. The secretion to be drained was yellow, thick secretion. The cavity was emptied from pus and flushed with saline. Patient was told to keep the area clean. The catheter kept the abscess open although it blocked the drainage. The device was without any remarks. Post-diagnosis of necrosis, the patient was prescribed tablet diclocil (dicloxacillin) 1 g x 4 for 10 days. Patient came back (b)(6) and she was much better. The abscess had healed good and she didn? T have any redness or pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02827 |
| MDR Report Key | 7894466 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-20 |
| Date of Report | 2018-11-06 |
| Date of Event | 2018-09-12 |
| Date Mfgr Received | 2018-10-24 |
| Date Added to Maude | 2018-09-20 |
| 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 | 2018-09-20 |
| Catalog Number | J-BGC-015055 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Other | 2018-09-20 |