DEVON
Received Aug 2, 2018 · Event occurred Apr 6, 2018
Report 1282497-2018-00640 · MDR key 7742412
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
- Appropriate Device Problem Term/Code Not Available
- Adverse Event Without Identified Device or Use Problem
Patient
90 YR
- Therapeutic Effects, Unexpected
- Ulceration
- Therapeutic Effects, Unexpected
- Ulceration
Narrative
Additional Manufacturer Narrative
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
CUSTOMER REPORTS: THE PATIENT PRESENTED A SMALL, DRY, RED (GRANULATING) WOUND ON THE ANTERIOR OF THE SHIN THAT WAS COVERED WITH A DRY DRESSING. THE COMMUNITY NURSES USED A DEVON UTILITY PAD FOLDED OVER BETWEEN THE LEGS TO RELIVE SOME PRESSURE FROM THE AREA. WITHIN THREE DAYS THE WOUND OVER DOUBLED IN SIZE AND SINCE THEN HAS CONTINUED TO DETERIORATE AND IS NOW DOWN TO TENDON.
Additional Manufacturer Narrative
NO LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY REPORT (DHR) WAS UNABLE TO BE PERFORMED. HOWEVER, ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. IN-PROCESS PROCEDURES ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT IN THE MANUFACTURING PROCESS. THESE CONTROLS INCLUDE, BUT ARE NOT LIMITED TO: MATERIAL VERIFICATION/CERTIFICATION PROCESSES, DIMENSIONAL SPECIFICATIONS, STATISTICAL SAMPLINGS, PERIODIC AUDITS, PROCESS INSPECTIONS, MACHINE MAINTENANCE/OPERATION AND PERSONNEL TRAINING AND CERTIFICATION. SINCE NO LOT NUMBER PROVIDED, A DATE OF MANUFACTURE COULD NOT BE DETERMINED. THIS PRODUCT WAS BEING USED FOR TREATMENT OR DIAGNOSIS. CUSTOMER PROVIDED INFORMATION ALSO RELAYED THAT THE NURSES SAY THEY HAVE NOW TURNED THE DEVON PAD AROUND USING THE FLAT SURFACE AGAINST THE SKIN. EMPLOYEES HAVE REITERATED THEY DON¿T ENCOURAGE THIS AS IT IS INCORRECT USE AND IT SHOULD BE CONSIDERED REMOVING THE PAD AND FINDING AN ALTERNATIVE. THE DEVICE WAS FOLDED OVER AND UTILIZED IN A NON-CONVENTIONAL METHOD. STANDARD WOUND CARE WOULD NOT PLACE PRESSURE ON A WOUND. WOUNDS ARE TYPICALLY IDENTIFIED AND DOCUMENTED WITH EACH VISIT. CHANGES TO THE WOUND CARE AND APPROPRIATE MEASURES SHOULD BE IMPLEMENTED. NO PRODUCT/SAMPLE WAS PROVIDED FOR EVALUATION. NO ADDITIONAL INFORMATION, PICTURES OR VIDEOS WERE RECEIVED. THEREFORE, A COMPREHENSIVE INVESTIGATION WAS UNABLE TO BE CONDUCTED. THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE UTILIZED FOR TRACKING AND TRENDING PURPOSES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.