MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-08-12 for ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM manufactured by Lifestream Purification Systems, Llc.
[1652792]
Pt received a colonic on (b)(6) 2010 at user facility. She arrived at 7:00 for a sixth visit to the clinic over a period of four months and was familiar and comfortable with the process. The session was normal with large amounts of waste material being passed. Patient's session lasted one hour, after which she remarked she was pleased with the session. She left composed, of her own accord, stating that she was glad she had come in. User facility received a call from a doctor at a nearby hospital 3 days later, (b)(6), who identified himself but briefly, said he had a pt with a perforated colon, and asked several questions about the procedure and equipment. The user facility owner answered his questions, to which he replied "interesting, very interesting. " he then abruptly hung up the phone before the practitioner could ask him to repeat his name or further identify himself but he did identify the pt as (b)(6). User facility received an uncertified legal letter on 7. 27. 2010 seeking damages for pt hospitalization on (b)(6) 2010 and a diagnosis of "punctured colon. " the hospital stay purportedly lasted five days but there was no indication of what treatment the pt received.
Patient Sequence No: 1, Text Type: D, B5
[8803125]
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 | 3003860916-2009-00001 |
| MDR Report Key | 1918602 |
| Report Source | 05 |
| Date Received | 2010-08-12 |
| Date of Report | 2010-08-11 |
| Date of Event | 2010-07-27 |
| Date Facility Aware | 2010-07-02 |
| Report Date | 2010-08-11 |
| Date Reported to Mfgr | 2010-07-27 |
| Date Mfgr Received | 2010-07-27 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2011-04-29 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM |
| Generic Name | 78KPL |
| Product Code | KPL |
| Date Received | 2010-08-12 |
| Model Number | CM-1 |
| Lot Number | NA |
| ID Number | AWSM06070106 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 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. Hospitalization | 2010-08-12 |