FDA Adverse Event Injury Summary report: N

GYPSONA S

MDR report key: 8326885 · Received February 11, 2019

Report

Report Number
MW5083887
Event Type
Injury
Date Received
February 11, 2019
Date of Event
November 5, 2018
Report Date
February 8, 2019
Manufacturer
BSN MEDICAL
Product Code
ITG
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

PATIENT RECEIVED PART AND FULL THICKNESS BURN TO POSTERIOR CALF RELATED TO EXOTHERMIC REACTION OF GYPSONA FAST-SET PLASTER USED IN POSTERIOR SPLINT. APPROPRIATE WETTING OF SPLINT MATERIAL WITH COOL WATER, APPROPRIATE PADDING, AND 10 THICKNESS OF PLASTER USED FOR POSTERIOR PORTION OF SPLINT. NO EXCESSIVE PRESSURE APPLIED TO PLASTER. SPLINT COVERED WITH FULL SUPER ACE ELASTIC BANDAGE. UPON SPLINT COMPLETION, PATIENT TRANSFERRED TO GURNEY FOR TRANSPORT TO RECOVERY. PATIENT'S LEG SUPPORTED BY PILLOW. PATIENT REPORTED BURNING PAIN IN CALF WHILE IN RECOVERY. GIVEN PAIN MEDICATION WITH SUITABLE RELIEF. POST-OP DAY ONE, PATIENT REPORTS BURN TO POSTERIOR CALF. SEES PROVIDER POST-OP DAY TWO. SPLINT TAKEN DOWN, REVEALING BURN. PATIENT SEEN BY BURN TEAM SAME DAY. EVENTUAL OUTCOME, PATIENT REQUIRED SPLIT THICKNESS SKIN GRAFT, RECOVERED WELL, NO RESIDUAL PAIN OR PARESTHESIA. ROOT CAUSE ANALYSIS PERFORMED. MANUFACTURER'S IFUS, ON SLIP OF PAPER IN SPLINTING MATERIAL BOX, REVEALS CAUTIONARY LANGUAGE ADVISING AGAINST SUPPORTING SPLINT WITH PILLOW, OVERWRAPPING, AND TO ENSURE GOOD AIRFLOW AROUND PLASTER AS IT SETS. IFUS WERE AVAILABLE, BUT RISK UNAPPRECIATED WITHIN ORGANIZATION. DURING RCA PRESENTATION TO JOINT COMMISSION ON 8 FEB 2019, IT WAS ADVISED TO COMPLETE A VOLUNTARY REPORT, EVEN THOUGH RCA REVEALED IMPROPER ADHERENCE TO GYPSONA PLASTER IFUS. COMPLETING REPORT BASED ON TJC RECOMMENDATION. DIAGNOSIS OR REASON FOR USE: POST-OPERATIVE LOWER EXTREMITY SPLINT. THERAPY START DATE: (B)(6) 2018, THERAPY END DATE: (B)(6)2018.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
119043 GYPSONA S BANDAGE CAST ITG BSN MEDICAL 825
119044 SUPER ACE BANDAGE CAST ITG UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 53 YR Other