MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2006-11-30 for ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM manufactured by Lifestream Purification Systems, Llc.
[3409169]
A (b)(6) female patient with no contraindications for colon hydrotherapy was referred to (b)(6) by a physician. She complained of a sharp pain in lower abdomen 5 minutes after commencing her colon hydrotherapy session. Session was immediately stopped, patient continued to cry out loudly and ems transport was offered. Patient refused transport asking to see dr. (b)(6), md, medical director of the spa. Dr. (b)(6) arrived at patient's side within ten minutes and her exam showed nothing. Patient continued to cry out loudly and ems was called. Ems found nothing and patient was taken to hospital and admitted. "rografia" (radiography) was conducted and surgical team brought in to examine patient and all found nothing. Physicians recommended discharge and follow-up general checkup. Patient was discharged on same day of event, (b)(6) 2006, but refused medical findings and suggestion of general check up. Patient's manner was contrary and she appeared upset that she had been cleared to leave. User facility commented that they suspected she might be a "provocateur. "
Patient Sequence No: 1, Text Type: D, B5
[10643238]
Patient was admitted to hospital on day of event (b)(6) 2006 and discharged the same day, a friday. On monday, patient checked herself into nephrology ward of a second hospital complaining of "intestinal" pain, where again, no medical diagnosis was given for her problem. She was transferred to surgical ward on (b)(6) and stayed there until (b)(6) undergoing a colonoscopy and other diagnostic tests. Patient complained constantly of what was translated as "intestinal interweave" or "punch" for which no medical evidence was found or charted for. Doctors in both hospitals failed to find evidence of colon perforation or any other pathological condition. Doctors gave uf staff assurance that they had observed due diligence in their immediate care of patient. Patient continued to insist that her care at the spa was faulty. Uf noted that patient abandoned complaint after patient's husband attempted to blackmail (called and demanded money from) the medical director of the uf, dr. (b)(6), md. Dr. (b)(6) refused the man's demands. User facility suspected a "sham" event from possible competitors for the entire incident. Mfr. Is reporting this event as "other" as we are required to report events resulting in ems transport directly from uf leading to hospitalization. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003860916-2006-00001 |
| MDR Report Key | 3035494 |
| Report Source | 01,06 |
| Date Received | 2006-11-30 |
| Date of Report | 2006-11-06 |
| Date of Event | 2006-10-20 |
| Date Facility Aware | 2006-10-20 |
| Report Date | 2006-11-06 |
| Date Reported to Mfgr | 2006-11-06 |
| Date Mfgr Received | 2006-11-06 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2013-04-18 |
| 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 | 2006-11-30 |
| Model Number | CM-1 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization | 2006-11-30 |