MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2017-01-03 for ANGEL OF WATER CM-1 COLON IRRIGATION SYSTEM manufactured by Lifestream Purification Systems, Llc.
[63769944]
Very little data is currently available to lifestream. Notice from (b)(6) was received on december 3, 2016 and an investigation has commenced. No other data, other than the one sentence provided by the (b)(6), is known at this time.
Patient Sequence No: 1, Text Type: N, H10
[63769965]
On 12/03/2016, a letter was received from the (b)(6), that an incident involving the aow cm-1 device had taken place in (b)(6) on (b)(6) 2016. The specific wording of the incident is as follows: "clinical event information: following the treatment (which was self-administered and without supervision) the complainant was in immediate pain and subsequently suffered a perforated bowel. " prior to this letter from the (b)(6), no notice was received by lifestream from a user facility or the complainant of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003860916-2016-00001 |
| MDR Report Key | 6219849 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2017-01-03 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-05-06 |
| Date Mfgr Received | 2016-12-03 |
| Date Added to Maude | 2017-01-03 |
| 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 | 0 |
| 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 CM-1 COLON IRRIGATION SYSTEM |
| Generic Name | COLON IRRIGATION EQUIPMENT |
| Product Code | KPL |
| Date Received | 2017-01-03 |
| Model Number | CM-1 |
| Catalog Number | CM-1 |
| Lot Number | N/A |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIFESTREAM PURIFICATION SYSTEMS, LLC |
| Manufacturer Address | 7303 BURLESON ROAD SUITE 801 AUSTIN TX 78744 US 78744 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2017-01-03 |