IONTOPHORETIC STIMULATOR (IONTO4)

Description of Event or Problem

NATUS RECEIVED NOTIFICATION OF A REPORT (MW5109076) RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM. GRD PLATE 1.0M LEAD 24 POCH/PK - CUSTOMER USED A DISPOSABLE GROUND PLATE ELECTRODE DURING QSART STUDY WHICH CAUSED A SMALL BLISTER 5 MILLIMETER BURN ON THE PATIENT'S FOREARM.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). NATUS RECEIVED NOTIFICATION OF A REPORT (MW5109076) RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM THE REPORT STATES THE CUSTOMER USED A NATUS DISPOSABLE GROUND PLATE ELECTRODE DURING A QSART STUDY WHICH CAUSED A SMALL BLISTER, FIVE MILLIMETER BURN ON PATIENT'S FOREARM. CUSTOMER RETURNED THE COMPLETED ADVERSE EVENT QUESTIONNAIRE. THE CUSTOMER REPORTS THAT THEY WERE USING A WR MEDICAL IONTO4 IONTOPHORETIC STIMULATOR (NON-NATUS DEVICE) WHEN THE EVENT OCCURRED. WR MEDICAL HAS RESPONDED TO THE CUSTOMER AND ADVISED THEY SHOULD NOT BE USING NATUS ELECTRODES WITH THE IONTO4 STIMULATOR. THE NATUS ELECTRODES ARE NOT COMPATIBLE WITH THE WR MEDICAL STIMULATOR AND THAT IS WHY THE BURN OCCURRED. PER COMPLETED ADVISE EVENT QUESTIONNAIRE THE PART IS NOT ABLE TO BE RETURNED AND THE LOT NUMBER OF THE ELECTRODES IS UNKNOWN. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED. PER (B)(4) ADHESIVE ELECTRODES RISK ANALYSIS SPREADSHEET, HAZARD ID - 13.1, SEVERITY - MARGINAL, THE RISK IS CONSIDERED LOW. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. PER (B)(4), COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. FURTHER REVIEW OF INVESTIGATION DETAILS TO BE CARRIED OUT.

Additional Manufacturer Narrative

FOLLOW UP REPORT 002 REF NATUS COMPLAINT#(B)(4). UPDATED SECTION D1, D2, D3 WITH REFERENCE TO THE BELOW : THE CUSTOMER REPORTS THAT THEY WERE USING A WR MEDICAL IONTO4 IONTOPHORETIC STIMULATOR (NON-NATUS DEVICE) WHEN THE EVENT OCCURRED. WR MEDICAL HAD RESPONDED TO THE CUSTOMER AND ADVISED THEY SHOULD NOT BE USING NATUS ELECTRODES WITH THE IONTO4 STIMULATOR. THE NATUS ELECTRODES ARE NOT COMPATIBLE WITH THE WR MEDICAL STIMULATOR AND THAT IS WHY THE BURN OCCURRED.

Description of Event or Problem

NATUS RECEIVED NOTIFICATION OF A REPORT (MW5109076) RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM. GRD PLATE 1.0M LEAD 24 POCH/PK - CUSTOMER USED A DISPOSABLE GROUND PLATE ELECTRODE DURING QSART STUDY WHICH CAUSED A SMALL BLISTER 5 MILLIMETER BURN ON THE PATIENT'S FOREARM.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT (B)(4). PER COMPLETED ADVISE EVENT QUESTIONNAIRE THE PART IS NOT ABLE TO BE RETURNED AND THE LOT NUMBER OF THE ELECTRODES IS UNKNOWN. FAILLURE CONFIRMED: NO. INVESTIGATION RESULT CODE: NEURO SBU/PRODUCT NOT RETURNED. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

Description of Event or Problem

NATUS RECEIVED NOTIFICATION OF A REPORT (MW5109076) RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM. GRD PLATE 1.0M LEAD 24 POCH/PK - CUSTOMER USED A DISPOSABLE GROUND PLATE ELECTRODE DURING QSART STUDY WHICH CAUSED A SMALL BLISTER 5 MILLIMETER BURN ON THE PATIENT'S FOREARM.