MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-08-19 for VISCERA RETAINER 3206 manufactured by Adept-med Intl., Inc..
[360314]
In 2004 received telephone call from lab conducting product testing which drew the sterility of the product into question.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918699-2004-00006 |
| MDR Report Key | 540063 |
| Report Source | 00 |
| Date Received | 2004-08-19 |
| Date of Report | 2004-08-19 |
| Date of Event | 2004-08-13 |
| Date Mfgr Received | 2004-08-13 |
| Device Manufacturer Date | 2004-02-01 |
| Date Added to Maude | 2004-08-23 |
| 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 | 0 |
| Manufacturer Street | 665 PLEASANT VALLET RD. |
| Manufacturer City | DIAMOND SPRINGS CA 95619 |
| Manufacturer Country | US |
| Manufacturer Postal | 95619 |
| Manufacturer Phone | 9499533110 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISCERA RETAINER |
| Generic Name | VISCERA RETAINER |
| Product Code | GCZ |
| Date Received | 2004-08-19 |
| Model Number | 3206 |
| Catalog Number | 3206 |
| Lot Number | 10503 |
| ID Number | NA |
| Device Expiration Date | 2005-10-30 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 529372 |
| Manufacturer | ADEPT-MED INTL., INC. |
| Manufacturer Address | * DIAMOND SPRINGS CA 95619 US |
| Baseline Brand Name | VISCERA RETAINER |
| Baseline Generic Name | VISCERA RETAINER |
| Baseline Model No | 3206 |
| Baseline Catalog No | 3206 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-19 |