PAIR OF LEG PLATES, 4-PART

Additional Manufacturer Narrative

THE IMPORTER REPORT WAS GENERATED AS A RESULT OF A MISTAKE IN THE DECISION TREE IN FOREIGN REPORTING COUNTRIES WHICH A COLLEAGUE AT THE MANUFACTURER STARTED CORRECTING AT THE EXACT TIME AS THE MFG EMDR INITIAL REPORT WAS SENT AND EMDR FOLLOW UP REPORT WAS GENERATING. AS THE DECISION TREE WAS CHANGED FROM VERSION 1 TO VERSION 2, A MISTAKE WAS MADE AND THEY CHOSE THE OPTION RESULTING IN ¿SERIOUS INJURY¿ WHICH WAS CORRECTED BEFORE THE DECISION TREE WAS CONFIRMED. UNFORTUNATELY, AS THE EMDR INITIAL (MANUFACTURER) WAS SENT AT THE SAME TIME, THE EMDR INITIAL FOR IMPORTER WAS AUTOGENERATED. THE INJURY IN THE COMPLAINT WAS NEVER CONSIDERED AS SERIOUS. IT HAS BEEN CONFIRMED THE INJURY OF THE USER WAS NOT SERIOUS. THEREFORE, THE IMPORTER REPORT IS NOT REQUIRED. THE INCIDENT WILL BE FURTHER INVESTIGATED UNDER MANUFACTURER REPORT REF.: 8010652-2023-00147 .

Description of Event or Problem

REF. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

Description of Event or Problem

ON 12TH DECEMBER 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF ACCESSORIES - 113373BC - PAIR OF LEG PLATES, 4-PART. AS IT WAS STATED, THE USER CUT THEIR INDEX FINGER WHEN REMOVING THE LEG PLATES. ACCORDING TO PROVIDED INFORMATION, THE CUT WAS SUPERFICIAL AND ONLY THE PLASTER WAS APPLIED. NO STITCHES WERE NECESSARY. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE USER'S BODY CUT DURING USE OF THE LEG PLATE, WAS TO REOCCUR.