| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-09-20 | 0 | 1. O |
Patient 1
(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 1
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.