MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,06 report with the FDA on 2007-03-07 for ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM manufactured by Lifestream Purification Systems, Llc.
[2040275]
On (b)(6) 2007, a (b)(6) female came to uf for a colon irrigation session, something she had experienced before. She filled out intake and consent forms, went through an orientation, and commenced a normal session. Pt felt cramping a few moments into the session, whereby the health practitioner turned off the flow of water and had the pt slide off the nozzle. After speaking together a few moments, the pt decided to have the water turned on again and took 3-5 gallons of water, after which the practitioner again stopped the flow of water due to continued cramping. This happened a third time and both patient and practitioner agreed to stop the session, though some cramping is well within the range of a normal session if a person has been having difficulty with their digestion or elimination. Pt stayed by herself in the room for a few minutes to redress and then spent 20 minutes talking with practitioner in check-out area before using the rest room, paying, discussing rescheduling, and taking leave. The pt reported no pain and left the clinic of her own accord.
Patient Sequence No: 1, Text Type: D, B5
[9236969]
On (b)(6) 2007, more than a month after the pt visited the (b)(6), the health practitioner received a letter from a personal injury attorney alleging that during the colon irrigation session on (b)(6) 2007 [sic], the pt's colon was punctured. The letter further alleged that the pt underwent reparative surgery, now has a temporary colostomy bag, and will need a second surgery. 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, which is reusable. The uf disposed of the used rectal nozzle, linens, etc in the normal way of disposing of medical waste. There was no evidence or blood or other abnormality in the irrigation room, on the supplies, or in the rest room used by the pt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003860916-2007-00001 |
| MDR Report Key | 2190164 |
| Report Source | 04,06 |
| Date Received | 2007-03-07 |
| Date of Report | 2007-02-20 |
| Date of Event | 2007-01-08 |
| Date Facility Aware | 2007-02-14 |
| Report Date | 2007-02-20 |
| Date Reported to Mfgr | 2007-02-20 |
| Date Mfgr Received | 2006-02-20 |
| Device Manufacturer Date | 2006-04-01 |
| Date Added to Maude | 2011-08-11 |
| 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 | 0 |
| 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 |
| 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 | 2007-03-07 |
| Model Number | CM-1 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 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. STE. G AUSTIN TX 78704 US 78704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-07 |