MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-12-23 for ANGEL OF WATER COLON IRRIGATION SYSTEM CM-1 manufactured by Lifestream Purification Systems, Llc.
[17608776]
Female pt was driven to the er in private car after feeling of cramping and nausea during colon hydrotherapy session. Pt was checked out at er by attending nurse/physician but not admitted to the hospital. No treatment was given. Pt reported that evening late that they were "feeling better. "
Patient Sequence No: 1, Text Type: D, B5
[17670679]
The part of the device referred to under "usage of device" is the angel of water disposable rectal nozzle, a sterile, single use dvice that is part of the angel of water colon irrigation system.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003860916-2010-00002 |
| MDR Report Key | 2948251 |
| Report Source | 05 |
| Date Received | 2010-12-23 |
| Date of Report | 2010-12-23 |
| Date of Event | 2010-12-15 |
| Date Facility Aware | 2010-12-15 |
| Report Date | 2010-12-23 |
| Date Reported to Mfgr | 2010-12-22 |
| Date Mfgr Received | 2010-12-22 |
| Date Added to Maude | 2013-02-08 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL OF WATER COLON IRRIGATION SYSTEM |
| Generic Name | 78KPL |
| Product Code | KPL |
| Date Received | 2010-12-23 |
| Model Number | CM-1 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFESTREAM PURIFICATION SYSTEMS, LLC |
| Manufacturer Address | 2001 S. LAMAR BLVD. SUITE G AUSTIN TX 78704 US 78704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-12-23 |