FDA Adverse Event Injury Summary report: N

NA

MDR report key: 2140505 · Received June 21, 2011

Report

Report Number
MW5021099
Event Type
Injury
Date Received
June 21, 2011
Date of Event
June 10, 2011
Report Date
June 21, 2011
Product Code
LNH
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

SWALLOWED MAGNETIC BB'S, -PRODUCT: BUCKEY BALLS- OR OTHER MAGNETIC TOYS, POSE A THREAT TO CHILDREN UNDERGOING AN MRI SCAN. A PERSON THAT HAS SWALLOWED ANY TYPE OF MAGNETIC TOY CAN BE INJURED IF ENTERING AN MRI MAGNET BECAUSE THE STRONG MRI MAGNET WILL ATTRACT THE TOY MAGNET-S- WHILE IN THE PT'S BELLY, POTENTIALLY CAUSING PERFORATIONS OF THE COLON. THIS THREAT IS ESPECIALLY HEIGHTENED IN CHILDREN, SINCE THE STANDARD SCREENING PROCESS USED IN MRI FACILITIES IS A SERIES OF VERBAL AND WRITTEN QUESTIONS GEARED TOWARDS RELIABLE INFO GIVEN BY THE PARENTS AND THE CHILD. FOR MANY REASONS, PARENTS WILL NOT KNOW THE CHILD HAS SWALLOWED THE TOYS. IE; CHILDREN DO NOT WANT THEIR PARENTS TO KNOW THEY HAVE SWALLOWED THE TOYS, AND OR THE CHILD MAY NOT BE ABLE TO COMMUNICATE THIS INFO WITH THE PARENTS. THIS HAZARD CAN BE AVOIDED BY ADDING THE USE OF HAND HELD METAL DETECTORS IN THE SCREENING PROCESS IN ORDER TO SENSE THE PRESENCE OF SWALLOWED MAGNETIC OBJECTS PRIOR TO ALLOWING ENTRY INTO THE MRI SCANNER. PT'S DOCTOR ORDERED AN MRI OF BRAIN AND CERVICAL SPINE FOR NECK PAIN. PT HAD PREVIOUS MRI FOR OF SAME ANATOMY FOR SAME REASON ON (B)(6). BECAUSE OF THE PT'S AGE, THE PT REQUIRED SEDATION WITH THE ASSISTANCE OF AN ANESTHESIOLOGIST FOR THE SCAN. ON (B)(6) , PT AND PARENTS WERE SCREENED WITH A WRITTEN AND VERBAL SCREENING PROCESS FOR PRESENCE OF METALLIC IMPLANTS AND ANY HISTORY OF SURGERY OR OTHER CONTRAINDICATIONS BEFORE UNDERGOING THE MRI. THE SCREENING REVEALED NO CONTRAINDICATIONS AND WAS CLEAR TO THEIR KNOWLEDGE SO THE MRI SCANS WERE STARTED. AFTER THE BRAIN SCAN WAS COMPLETED THE MRI TECH MOVED ON TO SCAN THE C SPINE AND NOTICED AN ARTIFACT, PRESUMABLY FROM SOME METAL SOMEWHERE AROUND OR ON THE PT. THE TECHNICIAN STOPPED THE SCAN AND BROUGHT THE PT OUT OF THE SCANNER TO EXAMINE THE AREA. AT THIS TIME, THE TECH FURTHER QUESTIONED THE FATHER ABOUT THE POSSIBILITY OF THERE BEING ANY METAL, OR ANY OTHER SUBSTANCE THAT MAY CONTAIN METAL IN, ON, OR AROUND THE PT'S UPPER ABDOMEN. THE PARENT SAID NO, THERE WAS NOT. KNOWING THE HISTORY OF PREVIOUS SCAN NINE DAYS EARLIER AND NO SURGICAL INTERVENTION SINCE (PER THE PARENTS), THE TECH CONTINUED THE SCAN. THE C SPINE SCAN WAS COMPLETED AND THE PT RETURNED TO RECOVERY, THEN TO THEIR ROOM IN THE HOSPITAL LATER THAT DAY. THE NEXT DAY, (B)(6), THE PT PRESENTED WITH ABDOMINAL SYMPTOMS. AN X-RAY OF THE ABDOMEN REVEALED ELEVEN METAL BB'S ALL ALIGNED TOGETHER IN THE UPPER ABDOMEN. PT'S SYMPTOMS WERE CONSISTENT WITH PERFORATIONS AND THE PT WAS TAKEN TO SURGERY TO HAVE THE BB'S REMOVED AND BELLY EXAMINED FOR PERFORATIONS. MULTIPLE BOWEL PERFORATIONS WERE FOUND AND TREATED. ELEVEN BB'S, ATTACHED TO EACH OTHER IN A LINE, WERE REMOVED. THE BB'S WERE IDENTIFIED BY THE SURGEON AS MAGNETIC BALLS, THE SIZE OF SMALL BB'S.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 NA MRI LNH

Patients

Seq Age Sex Outcome Treatment
1 5 YR Hospitalization| S