3M SCOTCHCAST ONE STEP SPLINT
Received Mar 6, 2015 · Event occurred Jan 23, 2015
Report 2110898-2015-00011 · MDR key 4595222
Device
Generic name
Prosthetic And Orthotic Accessory
Manufacturer
3m Health CareModel number
NACatalog number
86335
Lot number
2017-07 UG
Product problems
- Insufficient Device Problem Information
Patient
64 YR
- Irritation
- Skin Irritation
- Skin Inflammation
Narrative
Description of Event or Problem
A MALE HAD A 3M SPLINT PLACED ON HIS LEFT FOREARM AND ELBOW ON (B)(6) 2015 FOLLOWING AN ACCIDENT THE DAY BEFORE. THE SPLINT AND HIS ARM WERE WRAPPED IN AN ELASTIC BANDAGE. WITHIN THE NEXT FEW DAYS THE MALE ALLEGED BLISTERING AND WEEPING OF THE SKIN AROUND THE EDGE OF THE SPLINT. THE SPLINT WAS REMOVED AROUND (B)(6) 2015. THE MALE ALLEGED 2-3CM BLISTERS OVER HIS ARM; THE BLISTERS WERE ALLEGEDLY WORSE ON THE INNER SIDE OF THE ARM AND ON THE ELBOW JOINT. THE MALE WAS GIVEN AN UNIDENTIFIED STEROID INJECTION, FLUOCINONIDE CREAM, FUROSEMIDE (A DIURETIC) AND AN UNIDENTIFIED ANTIBIOTIC. HIS SURGERY WAS POSTPONED FOR ONE WEEK. ADDITIONAL INFORMATION PROVIDED BY THE MALE THAT OCCURRED SUBSEQUENT TO THE REPORTABLE EVENT NOTED ABOVE. THE MALE HAD SURGERY ON HIS LEFT ELBOW ON APPROXIMATELY (B)(6) 2015 THAT INVOLVED A JOINT IMPLANT (RADIAL HEAD). THE MALE ALLEGED HIS WOUND DID NOT HEAL ADEQUATELY. BACTRIM WAS PRESCRIBED WHICH HE STATED HAD NO EFFECT. THE IMPLANT WAS REMOVED AND A PICC LINE PLACED ON (B)(6) 2015 FOR RECEIVING IV VANCOMYCIN.
Additional Manufacturer Narrative
THIS IS A VERY RARE EVENT BASED ON PRODUCT COMPLAINT HISTORY.