MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-09 for SYPHILIS HEALTH CHECK manufactured by Vedalah.
[33163583]
(b)(6) operates a mobile outreach program in a high risk community of (b)(6). Services provided include testing for the presence of treponemal antibodies in clients lacking a history of syphilis. During the period referenced above 57 tests were performed with the device in question (syphilis health check). Of these 12 specimens generated reactive results. These specimens were submitted to a reference lab for confirmation utilizing rpr and fta. The results were discordant. As a result, it was decided to utilize the device in question within two of eight ambulatory centers operated by (b)(6) on specimens testing. Reactive in an on-site rpr and verified for rpr and fta by a reference lab. In this case, however, the results utilizing health check elicited a non reactive result. This occurred in three of nine specimens tested. Dates of use: 07/04/2015 - 10/21/2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5058414 |
| MDR Report Key | 5284925 |
| Date Received | 2015-12-09 |
| Date of Report | 2015-12-09 |
| Date Added to Maude | 2015-12-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYPHILIS HEALTH CHECK |
| Generic Name | HEALTH CHECK |
| Product Code | LIP |
| Date Received | 2015-12-09 |
| Model Number | NA |
| Lot Number | 07015 |
| Device Expiration Date | 2016-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VEDALAH |
| Manufacturer Address | CAPE MAY COURT HOUSE NJ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-09 |