PRIMO

Additional Manufacturer Narrative

THESE MEDICAL DEVICE REPORTS (MDRS) ARE BEING FILED PAST THE REGULATORY REPORTING TIMEFRAME AS THEY ARE A RESULT OF A RETROSPECTIVE REVIEW OF OUR COMPLAINTS. PRODUCT LOT NUMBERS WERE NOT PROVIDED, HOWEVER A REVIEW OF THE MANUFACTURING RECORDS FOR ALL PRODUCTION LOTS OF BPW04F AND BPW11F FOR THE LAST TWO YEARS WAS PERFORMED. ALL LOTS WERE PRODUCED ACCORDING TO SPECIFICATION AND NO PROCESS DEVIATIONS OR ABERRANT RESULTS WERE NOTED. ADDITIONALLY, ALL RELEASE CRITERIA WERE MET PRIOR TO RELEASE FOR EACH PRODUCTION LOT. A TREND ANALYSIS OF OUR COMPLAINT MANAGEMENT SYSTEM CONFIRMED THERE HAVE BEEN NO REPORTED COMPLAINTS DUE TO PRODUCT PERFORMANCE ASSOCIATED WITH ITEM NUMBER BPW04F AND BPW11F. FROM (B)(6) 2023, AREA VICE PRESIDENT OF SALES (AVP) VISITED THE CUSTOMER SITE AND ACCOMPANIED BOTH DAY SHIFT AND NIGHT SHIFT PERSONNEL IN CLINICAL AREAS. ADDITIONAL TRAINING INCLUDING AN OVERVIEW OF THE ASP GLOBAL TRAINING VIDEOS DEMONSTRATING PROPER USAGE OF THE PRIMO GUIDE & GLIDE ANGLED WEDGE BUNDLE WAS CONDUCTED WITH THE SITE CLINICAL DIRECTORS. UPON REQUEST, AN ADDITIONAL FOLLOW-UP VISIT TOOK PLACE (B)(6) 2023, TO PROVIDE REFRESHER TRAINING TO THE ENTIRE CLINICAL STAFF. THE REGIONAL SALES SPECIALIST ACCOMPANIED STAFF MEMBERS DURING CLINICAL MEETINGS AND DURING ROUNDING ACTIVITIES ON BOTH DAY AND NIGHT SHIFTS. ADDITIONAL REFRESHER TRAINING INCLUDING PRODUCT DEMONSTRATION AND REVIEW OF ASP TRAINING DEMONSTRATING PROPER USAGE OF THE PRIMO GUIDE & GLIDE BODY ANGLED WEDGE BUNDLE WAS CONDUCTED WITH THE ENTIRE CLINICAL STAFF. NO SERIOUS INJURY REPORTED.

Description of Event or Problem

ON (B)(6) 2023, CUSTOMER REPORTED THAT GGTS13F G&G ANGLED WEDGE BUNDLE STANDARD 13 COMPRESSED FLAT DURING USE AND CAUSED THREE PRESSURE INJURIES TO OCCUR IN (B)(6) 2023. ON (B)(6) 2023, ONE PATIENT SUFFERED DEEP TISSUE INJURY TO THE COCCYX AREA.