JIMMY JOHN III 2-C NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2000-06-23 for JIMMY JOHN III 2-C NA manufactured by Colon Therapeutics, Inc..

Event Text Entries

[166983] 6/5/00: client referred to new choices plus, inc. For a colonic. Note: colonics are self-administered by the client. Colonic devices are low-pressure systems - 1 to 3 psi. The client inserts their own rectal tip, turns on the device and controls the flow of water into their colon. A technician is available at all times with the use of a call button. The client is always in control of their colonic. Clients are always fully trained as to the operation and use of the device. Technician monitors client at 4 minute, 7 minute, and 10 minute intervals. 10:55 a. M. : client starts device. Technician monitors client to see that all is normal with client and steps out of the room. 11:01 a. M. : tech checks on client. Client used approx 6 gallons of water. With client's permission, tech applies light massage. 11:13 a. M. : tech goes in room. "nothing has let go," explains client. With client's permission tech applies light massage and client releases. Tech instructs again how to turn off device and use call button if needed. Client calls out and both techs enter room immediately. Client has abdominal pain. Tech advises client to turn off device. Client does not. Tech turns device off. Client is then instructed how to get off device and sit on the toilet to finish releasing. 11:20 a. M. : client is off the device and on the toilet. 11:30 a. M. : client demands to get back on the device to continue the colonic and does. Tech does not leave the room. The client is bearing down. Tech advises client not to bear down. Client continues. Tech advises client to turn off device. Client will not do so. Tech turns off device and advises client how to get off device. Tech notices blood in rectal tip and advises client of this. Tech advises client to view the blood. Client declines. Tech sanitizes the device. Tech asks client to view contents in toilet. No blood viewed in toilet. Client asks, "what should i do? " tech suggests client see the physician. 11:45 a. M. : client lies down on couch, and rests for approx 1 1/2 hours. 2:00 p. M. : client leaves clinic. 6/6/00: tech calls client to see how client is doing. Leaves a message. 6/7/00: client leaves message, needs to schedule another session as soon as possible. Tech returns call and leaves message with client's spouse. 6/8/00: client's referral calls to advise tech that client had surgery. 6/9/00: client's spouse calls to advise tech of surgery and asks tech not to call or visit client. Notes: there has been no contact with client and no communication from the client at this time.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1640200-2000-00001
MDR Report Key283678
Report Source05,06
Date Received2000-06-23
Date of Event2000-06-05
Date Mfgr Received2000-06-08
Device Manufacturer Date2000-03-01
Date Added to Maude2000-06-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactJIM GIROUARD
Manufacturer Street2909 MAIN AVE
Manufacturer CityGROVES TX 77619
Manufacturer CountryUS
Manufacturer Postal77619
Manufacturer Phone4099630300
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJIMMY JOHN III
Generic NameCOLON IRRIGATION
Product CodeKPL
Date Received2000-06-23
Model Number2-C
Catalog NumberNA
Lot Number*
ID Number*
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key274515
ManufacturerCOLON THERAPEUTICS, INC.
Manufacturer Address2909 MAIN AVE. GROVES TX 77619 US
Baseline Brand NameJIMMY JOHN III
Baseline Generic NameCOLON IRRIGATION EQUIPMENT
Baseline Model No2-C
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyJIMMY JOHN III
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK842083
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
10 2000-06-23

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