MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-07 for H. PYLORI STAT - PAK HP133 manufactured by Chembio Diagnostic Systems, Inc..
[26967360]
The product lot in question was bulk material for further packaging by (b)(4). Eval of device showed that it met release criteria.
Patient Sequence No: 1, Text Type: N, H10
[26967361]
On (b)(6) 2004, a distributor/repackager. (b)(4), emailed saying that hp111703/1 of h. Pylori stat- pak has given 18 negatives in a suspect population. Three of these were confirmed positive by elisa. There was no involvement in any death or serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2431980-2004-00001 |
| MDR Report Key | 5101371 |
| Date Received | 2004-12-07 |
| Date of Report | 2004-12-06 |
| Date of Event | 2004-10-13 |
| Date Mfgr Received | 2004-10-13 |
| Device Manufacturer Date | 2003-11-17 |
| Date Added to Maude | 2015-09-24 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 3661 HORSEBLOCK RD. |
| Manufacturer City | MEDFORD NY 11763 |
| Manufacturer Country | US |
| Manufacturer Postal | 11763 |
| Manufacturer Phone | 6319241135 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | H. PYLORI STAT - PAK |
| Generic Name | IVD. RAPID DETECTION OF AB TO H. PYLORI |
| Product Code | OWF |
| Date Received | 2004-12-07 |
| Returned To Mfg | 2004-11-22 |
| Catalog Number | HP133 |
| Lot Number | HP111703/1 |
| Device Expiration Date | 2005-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHEMBIO DIAGNOSTIC SYSTEMS, INC. |
| Manufacturer Address | MEDFORD NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-12-07 |