MCOMPASS BIOFEEDBACK 2-CHANNEL CATHETER
Received Mar 6, 2019 · Event occurred Feb 7, 2019
Report 8394217 · MDR key 8394217
Device
Generic name
Device, Biofeedback
Manufacturer
Medspira LlcModel number
RMD-002-004Catalog number
RMD-002-004
Lot number
19011401
Product problems
- Break
Patient
13140 DA
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
DURING BIOFEEDBACK SESSION, BALLOON PART OF THE BIOFEEDBACK CATHETER BROKE WHILE IN THE PATIENT. MANUFACTURER RESPONSE FOR ANORECTAL MANOMETRY CATHETER, MCOMPASS BIOFEEDBACK 2 CHANNEL ANORECTAL MANOMETRY CATHETER (PER SITE REPORTER). THIS IS THE FIFTH CASE OF THIS TYPE FOR THIS PARTICULAR DEVICE EXPERIENCED BY (B)(6) HOSPITALS OVER THE PAST SIX WEEKS. COMPANY HAS BEEN MADE AWARE AND HAS MADE ARRANGEMENTS TO REPLACE ALL EXISTING STOCK WITH THIS ADDITIONAL LOT NUMBER (SEE PREVIOUS REPORT). UNAWARE IF OTHER FOLLOW UP HAS OCCURRED.