InjuryFCE
MEDI-PAK CLEANSING ENEMA SET
Received Apr 22, 1994 · Event occurred Mar 29, 1994
Report 8144 · MDR key 8144
Device
Generic name
Enema Set
Manufacturer
General Medical Co.Model number
NACatalog number
159545
Lot number
4060-493
Patient
20 YR
Narrative
Description of Event or Problem
GENERAL MEDICAL CORP. RECEIVED A RESPONSE FROM THEIR MANUFACTURER, PLASCO, INC CONCERNING THIS UFR REPORT: AS THE MANUFACTURER OF THIS DEVICE, ON MAY 18, 1994 WE ALSO SUBMITTED AN MDR FOR THIS EVENT. OUR INVESTIGATION CLASSIFIED THIS EVENT AS A USER ERROR WITH NO CORRECTIVE ACTION REQUIRED. THE PRINTED DIRECTIONS FOR USE ON THE CARTON REQUIRE REMOVAL OF THE SHEATH FROM PRELUBRICATED TIP.