PENSAR MEDICAL MICRODOC DRESSING KIT

Additional Manufacturer Narrative

PENSAR ATTEMPTED TO OBTAIN THE OMITTED INFORMATION: 1. PATIENT INFORMATION A1-A6. 2. B6 RELEVANT TEST LABS - N/A. 3. B7 OTHER RELEVANT HISTORY -N/A. 4. D10 DATE OF CONCOMITANT THERAPY - UNKNOWN. THE COMPLAINT WAS RECEIVED AS A RESULT OF A SEALING ISSUE. LEAK AND/OR SEAL ISSUES ARE A COMMONLY KNOWN RISK FOR ALL NEGATIVE PRESSURE WOUND THERAPY DEVICES. NO DOCUMENTATION OF ANY HARM OR IMPACT TO PATIENT. AS DEVICE WAS NOT RETURNED FOR EVALUATION, ADDITIONAL TESTING WAS NOT PERFORMED. AFTER ADDITIONAL CONVERSATIONS WITH CLINICAL STAFF TO BEST PRACTICES OF OBTAINING AND MAINTAINING APPROPRIATE SEAL WITH THE DEVICE THE USAGE APPEARS TO HAVE BEEN REMEDIED. ADDITIONAL PRODUCT PROVIDED TO THE DISTRIBUTOR/USER AS REPLACEMENT. THIS REPORT IS BEING SUBMITTED BASED ON RE-EVALUATION OF REPORTABILITY REQUIREMENTS PER PENSAR CAPA 46.

Description of Event or Problem

CUSTOMER (B)(6) REPORTED POTENTIAL QUALITY ISSUES WITH THE MICRODOC WOUND DRESSING (P/N 4013 (SYSTEM P/N 4003, LOT 20250120)); THE DRESSING WAS REPORTED AS HAVING A LEAK. CUSTOMER STAFF PROVIDED ADDITIONAL APPLICATION TRAINING TO BEST PRACTICES IN AVOIDING LEAKS THROUGH ADHESIVE DRESSING APPLICATION. PATIENT(S) REQUIRED A NEW WOUND DRESSING. DEVICES WERE NOT RETURNED. REPLACEMENT PRODUCT PROVIDED. CONSERVATIVE DETERMINATION: MDR REPORTABLE.