MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2005-08-17 for manufactured by .
[7786919]
User facility was contacted several times in regards to product eval and no response. If additional info is available later in time, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1418479-2005-00027 |
| MDR Report Key | 743174 |
| Report Source | 05,06 |
| Date Received | 2005-08-17 |
| Date Mfgr Received | 2005-07-25 |
| Date Added to Maude | 2006-08-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | IOANA MARTA |
| Manufacturer Street | 353 CORPORATE WOODS PKWY |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8479558016 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | DWZ |
| Date Received | 2005-08-17 |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 730965 |
| Baseline Brand Name | GRASPING BIOPSY FORCEPS |
| Baseline Generic Name | GRASPING BIOPSY FORCEPS |
| Baseline Model No | 8383.471 |
| Baseline Catalog No | 8383.471 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-08-17 |