DEROYAL ABDOMINAL BINDER
Received May 20, 2014 · Event occurred Apr 23, 2014
Report 3005225477-2014-00011 · MDR key 3899045
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Rash
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT HAD A RASH.
Additional Manufacturer Narrative
INVESTIGATION FINDINGS: THE COMPLAINT SAMPLE WAS NOT RETURNED. THE BOM FOR THE A131067 WAS PRINTED ALONG WITH LATEX, LABELING, NPE, MSDS AND COC DUE TO A SIMILAR COMPLAINT (B)(4). NO MANUFACTURING ISSUE WAS FOUND. NO RECENT MATERIAL CHANGES HAVE BEEN MADE TO THE MATERIALS. RAW MATERIAL NUMBER (B)(4) MSDS/NPE/COC/LATEX ADDED AS WELL AS A131067 (SAME RAW MATERIALS JUST A DIFFERENT LENGTH TO THE A131056) REPORTS/LABELING AND THE BOM ARE ATTACHED (FROM (B)(4) ALSO REPORTED BY THIS CUSTOMER). CORRECTION: NONE REQUIRED. ROOT CAUSE ANALYSIS: UNABLE TO DETERMINE, SEVERAL FACTORS MAY CAUSE ALLERGIC REACTIONS INCLUDING PATIENTS OWN SENSITIVITY TO PRESCRIPTIONS/CHEMICALS/MATERIALS/DYES, (OTHER THAN LATEX) AS WELL AS HEAT RELATED RASHES. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: NO ACTION REQUIRED, NO MANUFACTURING ISSUE FOUND.