VECTRA GENISYS 2CH COMBO PKG US STD, 5CM APPL
Received Oct 13, 2021 · Event occurred Sep 13, 2021
Report 9616086-2021-00016 · MDR key 12628361
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Unknown
- Partial thickness (Second Degree) Burn
- Partial thickness (Second Degree) Burn
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A SECOND DEGREE BURN FROM TREATMENT. THE DEVICE WAS RETURNED TO DJO AND THE TECHNICIAN PERFORMED A THOROUGH INVESTIGATION. THE PRODUCT PASSED ALL FUNCTIONAL TESTING AND MET SPECIFICATIONS.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A SECOND DEGREE BURN FROM TREATMENT. DJO CONTINUES TO INVESTIGATE AND IF FURTHER INFORMATION IS RECEIVED, DJO WILL PROVIDE A SUPPLEMENTAL ONCE THE INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT ALLEGEDLY EXPERIENCED A SECOND DEGREE BURN FROM TREATMENT.