MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-09-18 for ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM manufactured by Lifestream Purification Systems, Llc.
[692032]
In 2007, a female came to uf for a colon irrigation session, something she had done before without issue in the same uf 3 days before. Patient felt cramping 20 minutes into the session, whereby the health practitioner turned off the flow of water and had the patient slide off the speculum and sit in the bathroom. Patient complained of nausea, whereby was given ammonia inhalent and protein bar and then lay on a biomat. The patient continued pale, weak, diaphoretic, and shaky. Practioner took pulse which was 88 and regular and then did a finger stick. Blood sugar was 145. After conferring together, patient agreed that practitioner could transport her to er ten minutes away. Patient was alert, oriented, and able to ambulate without difficulty though still pale and shaky. Patient vomited undigested food at the car and was seen right away at er. Was given iv, blood taken. Elevated wbc count prompted cat scan. Patient admitted on six days later in good form after antibiotics, a second cat scan, no surgeries.
Patient Sequence No: 1, Text Type: D, B5
[7877454]
Barbara bock called a doctor acquaintance of hers who spoke with the treating physician. Learned that the patient had a recent colonoscopy ( 3 weeks ago and not 3 months ago as indicated on intake form). Was diagnosed with diverticulum. The colonic may have opened a small pocket. Doctor said elevated wbc count on admission could not have been caused by colonic irrigation but may have been pre-existent from some condition post-colonoscopy. The part of the device referred to under "usage of device" is the angel of water disposable rectal nozzle, a sterile, single use device that is part of the angel of water colon irrigation system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003860916-2007-00002 |
| MDR Report Key | 918052 |
| Report Source | 06 |
| Date Received | 2007-09-18 |
| Date of Report | 2007-08-08 |
| Date of Event | 2007-08-02 |
| Date Facility Aware | 2007-08-02 |
| Report Date | 2007-08-22 |
| Date Reported to Mfgr | 2007-08-08 |
| Date Mfgr Received | 2007-08-08 |
| Device Manufacturer Date | 2003-10-01 |
| Date Added to Maude | 2007-11-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 2001 S. LAMAR BLVD. STE. G |
| Manufacturer City | AUSTIN TX 78704 |
| Manufacturer Country | US |
| Manufacturer Postal | 78704 |
| Manufacturer Phone | 5127078383 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM |
| Generic Name | 78 KPL |
| Product Code | KPL |
| Date Received | 2007-09-18 |
| Model Number | CM-1 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 902649 |
| Manufacturer | LIFESTREAM PURIFICATION SYSTEMS, LLC |
| Manufacturer Address | 2001 SOUTH LAMAR BLVD. SUITE G AUSTIN TX 78704 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2007-09-18 |