INNOVO, TYPE NUMBER 208
Received Aug 3, 2023 · Event occurred May 12, 2021
Report 3015223097-2023-00011 · MDR key 17451748
Device
Generic name
Cutaneous Electrode Stimulator For Urinary Incontinence
Manufacturer
Atlantic Therapeutics LtdModel number
208Catalog number
0208-5010
Lot number
20190706
Product problems
- Stretched
- Stretched
Patient
72 YR · Female
- Numbness
- Insufficient Information
- Numbness
- Insufficient Information
Narrative
Description of Event or Problem
FINAL REPORT SUBMITTED WITH NO ADDITIONAL INFORMATION. RETROSPECTIVE REVIEW OF SIMILAR EVENTS - NO PATIENT INJURY OR HARM. COMPLAINT NUMBER: (B)(4) WAS REPORTED IN THE US ON 17TH MAY 2021 WITH TRANSIENT NUMBNESS OF THE LEFT LEG FOLLOWED BY CHEST PAIN RESOLVED WITHIN 3 - 5 MINUTES FROM DEEP BREATHING. NO REPORTED LONG TERM HEALTH OR INJURY. NO REPORTED DEVICE DEFECT. CUSTOMER REPORTED A MEDICAL HISTORY OF BREAST CANCER WITH LYMPECTOMY RADIATION AND CHEMOTHERAPY. CUSTOMER ALSO REPORTED VARICOSE VEINS IN THE CALF AREA AND LEGS. THE INNOVO DEVICE WAS RETURNED ON THE 26TH MAY 2021 AND INSPECTED FOR DEFECTS ON THE 14TH MARCH 2022 .THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED WITH TEARS EVIDENT ON VISUAL INSPECTION.
Description of Event or Problem
RETROSPECTIVE REVIEW OF SIMILAR EVENTS - NO PATIENT INJURY OR HARM. COMPLAINT NUMBER: (B)(4) WAS REPORTED IN THE US ON (B)(6) 2021 WITH TRANSIENT NUMBNESS OF THE LEFT LEG FOLLOWED BY CHEST PAIN RESOLVED WITHIN 3 - 5 MINUTES FROM DEEP BREATHING. NO REPORTED LONG TERM HEALTH OR INJURY. NO REPORTED DEVICE DEFECT. CUSTOMER REPORTED A MEDICAL HISTORY OF BREAST CANCER WITH LYMPECTOMY RADIATION AND CHEMOTHERAPY. CUSTOMER ALSO REPORTED VARICOSE VEINS IN THE CALF AREA AND LEGS. THE INNOVO DEVICE WAS RETURNED ON THE (B)(6) 2021 AND INSPECTED FOR DEFECTS ON THE (B)(6) 2022 .THE INNOVO DEVICE WAS FOUND TO HAVE STRETCHED WITH TEARS EVIDENT ON VISUAL INSPECTION.