PROFORE LITE SYSTEM KIT CASE 8
Received Feb 23, 2020 · Event occurred Feb 3, 2020
Report 8043484-2020-00128 · MDR key 9743058
Device
Generic name
Dressing, Compression
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
66000415
Lot number
661886
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
THE DEVICE USED IN TREATMENT, HAS UNDERSTANDABLY NOT BEEN RETURNED, HOWEVER PHOTOS OR A CONTROL SAMPLE HAS NOT BEEN PROVIDED FOR EVALUATION. WITHOUT THIS WE ARE UNABLE TO COMPLETE AN ANALYSIS TO ESTABLISH A RELATIONSHIP BETWEEN DEVICE AND THE EVENT REPORTED. NO CLINICAL/MEDICAL DOCUMENTS OR PICTURES HAVE BEEN PROVIDED FOR THIS INVESTIGATION. WITHOUT SUPPORTING CLINICAL/MEDICAL DOCUMENTS, A THOROUGH INVESTIGATION CANNOT BE PERFORMED. SHOULD INFORMATION BECOME AVAILABLE THIS COMPLAINT CAN BE RE-ASSESSED. A RISK MANAGEMENT REVIEW HAS TAKEN PLACE IN RELATION TO THIS COMPLAINT. THE RISK FILE STATES THAT LOCAL INFECTION AND MACERATION CAN BE CAUSED WHEN EXUDATE SOAKS THROUGH THE BANDAGE. ALSO STATED IS THAT INCORRECTLY APPLIED BANDAGES, PATIENT TAMPERING AND BANDAGES NOT LEFT ON LONG ENOUGH MAY ALSO LEAD TO LOCAL INFECTION AND DELAYED WOUND HEALING. A REVIEW OF THE INSTRUCTIONS FOR USE FOUND ADEQUATE WARNINGS, PRECAUTIONS RELATING TO THE PRODUCT RANGE. PROFORE IS A MULTI-LAYER COMPRESSION BANDAGING SYSTEM DEVELOPED TO APPLY SUSTAINED GRADUATED COMPRESSION FOR THE MANAGEMENT OF VENOUS LEG ULCERS AND ASSOCIATED CONDITIONS THE IFU NOTES, THE PRESSURE UNDER THE BANDAGE COULD BRUISE AND HARM UNPROTECTED / UNPADDED SKIN ESPECIALLY OVER BONY PARTS OF THE LEG. A REVIEW OF THE DEVICE HISTORY SHOWED THAT THIS UNIT PASSED ALL ACCEPTANCE CRITERIA AND WAS COMPLIANT UPON RELEASE FOR DISTRIBUTION. THERE WERE NO INDICATIONS TO SUGGEST THE DEVICE DID NOT MEET PRODUCT SPECIFICATIONS NOR DID IT ALLEGE ANY PRODUCT DEFICIENCIES. COMPLAINT HISTORY FOR THE REPORTED FAILURE HAS BEEN REVIEWED, REVEALING NO FURTHER INSTANCES. NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. THIS INVESTIGATION HAS NOW BEEN CLOSED AND RECORDED AS INSUFFICIENT INFORMATION TO DETERMINE A ROOT CAUSE. WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.
Description of Event or Problem
IT WAS REPORTED THAT THE PROFORE WCL MESH DAMAGED THE SURROUNDING SKIN OF THE PATIENT AND NEW WOUNDS WERE CREATED.