SAGER EMERGENCY SPLINT
Received Sep 12, 2022 · Event occurred Jun 18, 2020
Report 3012307300-2022-18643 · MDR key 15401687
Device
Generic name
Splint, Extremity, Non-inflatable, External, Non-
Manufacturer
Smiths Medical International, Ltd.Catalog number
W8875/CE
Product problems
- Separation Problem
- Separation Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO LOT NUMBER WAS PROVIDED, THEREFORE, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. A PRODUCT SAMPLE AND PHOTO WERE RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED AND CONFIRMED THAT THE REPORTED PART WAS BROKEN. THE ROOT CAUSE OF THE REPORTED ISSUE WAS UNABLE TO BE DETERMINED. UDI IS UNKNOWN. NO INFORMATION HAS BEEN PROVIDED TO DATE. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT BUCKLE OF THE THIGH STRAP BROKE. NO PATIENT INJURY WAS REPORTED.