GYPSONA S

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-11 for GYPSONA S manufactured by Bsn Medical.

Event Text Entries

[135776406] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5083887
MDR Report Key8326885
Date Received2019-02-11
Date of Report2019-02-08
Date of Event2018-11-05
Date Added to Maude2019-02-11
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameGYPSONA S
Generic NameBANDAGE CAST
Product CodeITG
Date Received2019-02-11
Lot Number825
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBSN MEDICAL

Device Sequence Number: 2

Brand NameSUPER ACE
Generic NameBANDAGE CAST
Product CodeITG
Date Received2019-02-11
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-02-11

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