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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GIVEN IMAGING PILLCAM SB2 CAPSULE
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GIVEN IMAGING PILLCAM SB2 CAPSULE Back to Search Results
Model Number PILLCAM SB2 CAPSULE
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Obstruction/Occlusion (2422)
Event Date 11/21/2014
Event Type  No Answer Provided  
Event Description
The patient is a (b)(4) female with crohn's disease.The capsule was administered in the first two weeks of (b)(6) 2014.A ct scan done on (b)(6) 2014 demonstrated that the capsule was still in the patient.The radiologist interpreting the exam questioned whether the capsule was disrupted.According global director, (b)(4) medical development the scot image and ct images look like an intact capsule.On (b)(6) 2014, the patient had a surgery and an intact capsule was removed, along with two large rust colored pills.
 
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Brand Name
PILLCAM SB2 CAPSULE
Type of Device
PILLCAM SB2 CAPSULE
Manufacturer (Section D)
GIVEN IMAGING
hermon building, new industrial park
p.o. box 258
yokneam 2069 2
IS  20692
MDR Report Key4435592
MDR Text Key5378640
Report Number9710107-2014-00251
Device Sequence Number1
Product Code NEZ
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
K10250
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/15/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2014
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberPILLCAM SB2 CAPSULE
Device Catalogue NumberFGS-0179
Device Lot NumberNOT AVAILABLE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
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