BELKYRA SKIN GRID
Received Jul 25, 2023 · Event occurred Jul 3, 2023
Report 2024601-2023-00004 · MDR key 17393262
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
57 YR · Female
- Abscess
- Abscess
Narrative
Additional Manufacturer Narrative
CONTINUED H.6. HEALTH EFFECT - IMPACT CODES: F2303, F15. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem
HEALTHCARE PROFESSIONAL REPORTED INJECTING A PATIENT WITH 4 ML OF BELKYRA¿. IT WAS NOT REPORTED IF THE BELKYRA¿ SKIN GRID WAS USED. TEN DAYS LATER, PATIENT REPORTED REDNESS AND SWELLING. PATIENT WAS INSTRUCTED TO CONTINUE ICE PACKS AND ROLL THE HARDNESS PART DAILY 2 DAYS LATER. THE NEXT DAY, PATIENT PRESCRIBED ANTIBIOTICS. THE EVENT GOT WORSE 4 DAYS LATER AND THE PATIENT WAS ADVISED TO GO THE HOSPITAL, WHERE A CT SCAN WAS PERFORMED THAT NOTED ABSCESS SUPERFICIAL TO PLATYSMA. ABSCESS WAS DRAINED AND PATIENT WAS GIVEN IV CEFTRIAXONE + FLUCLOXACILLIN, ANALGESIA. PATIENT WAS DISCHARGED SAME DAY WITH AUGMENTIN DUO FORTE AND ENDONE (OXYCODONE). THE EVENT STATUS IS UNKNOWN.