FDA Adverse Event Other Summary report: N

HOVERSLING REPOSITIONG SLING

MDR report key: 17049386 · Received June 2, 2023

Report

Report Number
17049386
Event Type
Other
Date Received
June 2, 2023
Date of Event
May 7, 2023
Report Date
May 25, 2023
Manufacturer
D.T. DAVIS ENTERPRISES LTD. DBA HOVERTECH INTERNATIONAL
Product Code
FRZ
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

PATIENT HAD PLANNED C-SECTION MAIN OR FOR PREVIA, POSSIBLE ACCRETA. NO ACCRETA FOUND DURING CASE AND PATIENT MOVED TO L&D PACU (LABOR AND DELIVERY POST-ANESTHESIA CARE UNIT). AFTER 30 MINUTES IN PACU, PATIENT BEGAN HEMORRHAGING AND WAS MOVED TO OR B. PT WAS HEMODYNAMICALLY UNSTABLE AND DECISION FOR HYSTERECTOMY WAS MADE; PATIENT WAS PUT UNDER GENERAL ANESTHESIA. NO COUNT WAS PERFORMED BEFORE HYSTERECTOMY INCISION D/T EMERGENT NATURE OF CASE. ON FIRST X-RAY, A SMALL "RIBBON-LIKE" BAND WAS NOTED ON PATIENT'S LEFT ABDOMEN. FIRST READ WAS EXTREMELY DELAYED DUE TO LACK OF RADIOGRAPHER. MDS CALLED FOR SECOND X-RAY WHICH WAS EXTREMELY DELAYED DUE TO LACK OF TECH. UPON SECOND READ, IT WAS DETERMINED THE RIBBON WAS CAUSED FROM THE STITCHING OF THE HOVERMAT UNDERNEATH THE PATIENT. X RAY WAS FOUND TO BE CLEAR ONCE HOVERMAT STITCHING WAS CLEARED FROM UNDERNEATH PATIENT. IT WOULD BE MY RECOMMENDATION TO STREAM THE PROCESS OF A RADIOLOGY READ WHEN IN SURGERY AND ALSO TO NOTIFY STAFF THAT OUR HOVERMAT STITCHING DOES APPEAR ON X-RAY SO THE PLACEMENT SHOULD BE CHECKED PRIOR TO AN X-RAY. THERE WAS NO DEFECT IN THE PRODUCT THAT CAUSED HARM, HOWEVER THERE IS A SAFETY CONCERN IN THAT THE STITCHING OF THE HOVERMAT SHOWS UP ON X-RAY. WE HAD A PATIENT UNDERGO AN X-RAY WHILE LAYING ON TOP OF THE HOVERMAT WHEN A SMALL RIBBON-LIKE BAND WAS NOTED IN THE PATIENT'S ABDOMEN. ON SECOND READ OF THE X-RAY, IT WAS DETERMINED THAT THE RIBBON-LIKE BAND WAS CAUSED FROM THE STITCHING OF THE HOVERMAT. ONCE THE HOVERMAT WAS REMOVED AND A REPEAT X-RAY WAS TAKEN, THERE WAS NO LONGER A RIBBON-LIKE BAND IN THE ABDOMEN. THE REQUEST IS FOR CLARITY ON WHETHER THE MANUFACTURER IS AWARE THAT THE STITCHING IN THE HOVERMAT SHOWS UP ON X-RAYS OR IF THIS WAS A BAD BATCH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1186055 HOVERSLING REPOSITIONG SLING DEVICE, PATIENT TRANSFER, POWERED FRZ D.T. DAVIS ENTERPRISES LTD. DBA HOVERTECH INTERNATIONAL HMSLING-50RS-B HOV230312RE50M

Patients

Seq Age Sex Outcome Treatment
1 13140 DA Female