TREATMENT RECLINER
Received Oct 27, 2025
Report 0001831750-2025-99339 · MDR key 23391979
Device
Generic name
Chair, Examination And Treatment
Manufacturer
Stryker Medical-kalamazooCatalog number
3500000710
Product problems
- Sharp Edges
- Sharp Edges
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE(S) WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE(S) WAS/WERE REPAIRED AND RETURNED TO USE. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS): 1 DEVICE: PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE / FRACTURE PROBLEM. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.
Description of Event or Problem
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED ACCESSIBLE SHARP EDGES EXPOSED (METAL). NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.