MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2004-07-07 for VISCERA RETAINER, FISH UNK manufactured by Adept-med Intl., Inc..
[16765769]
Pt underwent abdominal surgery to remove an adept-med medical device i. E. A glassman viscera retainer, fish, which contrary to express labeling instructions, was "inadvertently left in their abdomen" during a previous abdominal surgery in either 1974, 1998 or two surgeries in 1999.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2918699-2004-00001 |
| MDR Report Key | 533903 |
| Report Source | 00 |
| Date Received | 2004-07-07 |
| Date of Report | 2004-07-07 |
| Date Mfgr Received | 2004-06-21 |
| Date Added to Maude | 2004-07-14 |
| 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 | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 665 PLEASANT VALLEY RD. |
| Manufacturer City | DIAMOND SPRINGS CA 95619 |
| Manufacturer Country | US |
| Manufacturer Postal | 95619 |
| Manufacturer Phone | 5306211220 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISCERA RETAINER, FISH |
| Generic Name | VISCERA RETAINER, FISH |
| Product Code | GCZ |
| Date Received | 2004-07-07 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 523171 |
| Manufacturer | ADEPT-MED INTL., INC. |
| Manufacturer Address | * DIAMOND SPRINGS CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-07-07 |