N
Patient 1
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
MAUDE MDR 6681539
- MDR report key
- 6681539
- Report number
- 2183164-2017-05001
- Event key
- 0
- Event type
- 3
- Date received
- 2017-06-30
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- EDWARD ALMEIDA
- Address
- 15 HAMPSHIRE STREET MANSFIELD MA 02048 US
- Phone
- 508-508-5084
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-06-30 | 0 | 1. O |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED PATIENT RECEIVED SKIN IRRITATION FROM ELECTRODE USE. OPEN SORE THE SIZE OF A DIME.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
N
Patient 1
THERE WERE SAMPLES SUBMITTED WITH THIS COMPLAINT. BASED ON THE RETURNED PRODUCT, THE ANALYSIS DID NOT CONFIRM THE REPORTED CONDITION OR INCIDENT. THE PRODUCT DID MEET THE PRODUCT SPECIFICATIONS. THE HYDROGEL HAD MINIMAL ADHESION WHEN TOUCHED WEARING NITRILE GLOVES. THE POUCH HAD TWO HOLES PUNCHED IN THE BOTTOM, WHICH COULD COMPROMISE THE EFFECTIVENESS OF THE TAMPER PROOF ZIPLOCK POUCH AND REDUCE THE MOISTURE IN THE HYDROGEL. ALL FOUR USED ELECTRODES WERE IMPEDANCE TESTED. THE 2" X 3.5" ELECTRODES MEASURED 75 AND 72 OHMS. THE 2" X 2" ELECTRODES MEASURED 254 AND 202 OHMS. NEW ELECTRODES HAVE AN UPPER SPECIFICATION OF 150 OHMS, SO THE 2" X 2" ELECTRODES WERE ABOVE THE SPECIFICATION FOR NEW ELECTRODES. IMPEDANCE ABOVE 150 OHMS ON USED ELECTRODES IS NOT UNCOMMON AND CAN BE CAUSED BY CONTAMINATION ON THE HYDROGEL OR LOSS OF MOISTURE. THE TWO ELECTRODES THAT MEASURED ABOVE 150 OHMS WERE RE-WET TO ASSESS MOISTURE CONTENT AND RE-TESTED. DURING THE RE-TEST, THE ELECTRODES MEASURED 124 AND 135 OHMS. THE DEVICE HISTORY RECORD (DHR) REVIEW SHOWED THAT ALL ACCEPTANCE CRITERIA INSPECTIONS PER ESTABLISHED SAMPLING LEVELS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. THE INVESTIGATION DETERMINED THAT THE MOST PROBABLE ROOT CAUSE IS DUE TO IMPROPER APPLICATION/RE-APPLICATION AND STORAGE OF ELECTRODES. DUE TO THAT FACT THAT NO COMPLAINT TREND EXISTS AND A ROOT CAUSE FOR THE REPORTED CONDITION CANNOT BE SPECIFICALLY IDENTIFIED; THEREFORE, CORRECTIVE ACTION WILL BE LIMITED TO THE MANUFACTURING AWARENESS. NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS COMPLAINT WILL BE RECORDED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.