PILLING WECK FR 24 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-14 for PILLING WECK FR 24 * manufactured by Pilling Weck.

Event Text Entries

[185239] During procedure a bougie dilator (esophagus) was transected inside the stomach allowing mercury from the dilator to escape. The bougie dilator was immediately removed from the pt's body and contained in a plastic bowl with a lid. The pediatric nurse clinician was immediately alerted to the incident. Pediatric nurse clinician called poison control and was told to shoot x-ray. Mercury level was drawn from the pt and an x-ray taken. Mercury noted in the x-ray. New suction container was obtained to suction mercury.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	240136
MDR Report Key	240136
Date Received	1999-09-14
Date of Report	1999-09-10
Date of Event	1999-09-09
Date Facility Aware	1999-09-09
Report Date	1999-09-10
Date Reported to Mfgr	1999-09-10
Date Added to Maude	1999-09-17
Event Key	0
Report Source Code	User Facility report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	PILLING WECK
Generic Name	BOUGIE DIALATOR FR 24
Product Code	KCD
Date Received	1999-09-14
Model Number	FR 24
Catalog Number	*
Lot Number	*
ID Number	*
Device Expiration Date	1996-01-30
Operator	HEALTH PROFESSIONAL
Device Availability	Y
Device Age	5 YR
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	232689
Manufacturer	PILLING WECK
Manufacturer Address	420 DELAWARE DR FORT WASHINGTON PA 19034 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1999-09-14