MAUDE Adverse Event Report: UNKNOWN SUPER ACE; BANDAGE CAST

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Full thickness (Third Degree) Burn (2696)

Event Date 11/05/2018

Event Type  Injury  

Event Description

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.

• Brand Name: SUPER ACE
• Type of Device: BANDAGE CAST
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8326885
• MDR Text Key: 135776406
• Report Number: MW5083887
• Device Sequence Number: 2
• Product Code: ITG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR