FDA Adverse Event Injury Summary report: N

BOWER RING PEG SYSTEM

MDR report key: 1685 · Received November 3, 1992

Report

Report Number: 33268-1992-00001
Event Type: Injury
Date Received: November 3, 1992
Date of Event: October 7, 1992
Report Date: October 19, 1992
Manufacturer: CORPAK, INC.
Product Code: EZL
Adverse Event: Yes
Report Source: Distributor report
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

PATIENT HAD TUBE INSERTED ON 10/5/92 @ 10:30 A.M. THE TUBE WAS CLOSED OFF UNTIL 10 A.M. ON 10/6/92 @ WHICH TIME AN ENTERAL FEEDING WAS STARTED @ 50ML/HR. AT 0545 10/7/92 THE NURSE WAS UNABLE TO INSTILL ANYTHING INTO THE TUBE BUT FLUID FLOWED OUT OF THE TUBE. THE PHYSICIAN WAS NOTIFIED ET THE ETERAL FEEDING STOPPED. THE PATIENT WAS X-RAYED AND CT SCANNED @ NOON ON 10/7/92 ET REVEALED THE TUBE DISLODGED FROM THE STOMACH. THE TUBE WAS REMOVED ON 10/7/92 @ 1700 HOURS. PHYSICIAN REPORTS REMOVING THE TUBE WITHOUT CUTTING BELOW THE ORANGE PIN. ON EXAMINATION, HE REPORTS THE BALLOON BEING COLLASPEDDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	BOWER RING PEG SYSTEM Implant	PEG KIT	EZL	CORPAK, INC.	30-6020	A06BH

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Other