MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-12 for WATER WORKS manufactured by Abbott Research Group.
[1466148]
Instructions for use read "use tap water". Patient does not have city water and developed an infection. Chronic pelvic pain, pid and bacterial vaginosis. System is not safe.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5017708 |
| MDR Report Key | 1869048 |
| Date Received | 2010-10-12 |
| Date of Report | 2010-10-12 |
| Date of Event | 2010-10-01 |
| Date Added to Maude | 2010-10-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WATER WORKS |
| Generic Name | HOMEDOUCHE SYSTEM |
| Product Code | HED |
| Date Received | 2010-10-12 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT RESEARCH GROUP |
| Manufacturer Address | 235 ALPHA DR. PITTSBURGH PA 15238 US 15238 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2010-10-12 |