MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-06-21 for manufactured by .
[7841285]
The product was not destroyed. The pt has the product. H3. The acorn product is being held by the pt. No eval can be done.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1418479-2006-00014 |
MDR Report Key | 728546 |
Report Source | 00 |
Date Received | 2006-06-21 |
Date Mfgr Received | 2006-05-30 |
Date Added to Maude | 2006-06-27 |
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 | ELEANOR HALL |
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 | HDP |
Date Received | 2006-06-21 |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Device Sequence No | 1 |
Device Event Key | 716838 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2006-06-21 |