SMARTPILL GI MONITORING SYSTEM PH.P CAPSULE 50100100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-06 for SMARTPILL GI MONITORING SYSTEM PH.P CAPSULE 50100100 manufactured by The Smartpill Corporation.

Event Text Entries

[2506472] The subject had difficulties swallowing the capsule. Additional water and apple sauce were given, but the subject vomited the capsule. He agreed to make a second effort, but experienced discomfort again and a feeling that the capsule was lodged in his throat. He vomited a couple of times and was referred to the er for evaluation. An x-ray image showed the capsule in the gastro-esophageal junction. Since the conservative treatment of liquid and bread did not resolve the problem, a gi consolation was requested. The gastroenterologist ordered endoscopic removal due to the smartpill wedge in the lower esophageal sphincter, causing acute obstruction. The subject was transferred back to the unit in the evening, he was on a liquid diet yesterday and he will be on a puree diet for two more days.
Patient Sequence No: 1, Text Type: D, B5


[9562461] Pt had last follow-up visit on (b)(6) 2011. At that time there was no permanent disability or impairment. No additional patient follow-up is planned or needed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1320877-2011-00002
MDR Report Key2380513
Report Source05
Date Received2011-09-06
Date of Report2011-09-02
Date of Event2011-08-05
Date Mfgr Received2011-08-06
Device Manufacturer Date2011-04-26
Date Added to Maude2011-12-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR RONALD BRANDT
Manufacturer Street847 MAIN ST.
Manufacturer CityBUFFALO NY 142031109
Manufacturer CountryUS
Manufacturer Postal142031109
Manufacturer Phone7168820701
Manufacturer G1THE SMARTPILL CORPORATION
Manufacturer Street847 MAIN ST.
Manufacturer CityBUFFALO NY 14203110
Manufacturer CountryUS
Manufacturer Postal Code14203 1109
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSMARTPILL GI MONITORING SYSTEM
Generic NameGASTROINTESTINAL MOTILITY CAPSULE
Product CodeNYV
Date Received2011-09-06
Model NumberPH.P CAPSULE
Catalog Number50100100
Lot NumberSPC1111601
Device Expiration Date2012-01-15
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTHE SMARTPILL CORPORATION
Manufacturer Address847 MAIN ST. BUFFALO NY 14203110 US 14203 1109


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2011-09-06

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