MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2008-02-15 for SELECTOR INTEGRA USA 1530000M3 manufactured by Integra Neurosciences, Ltd..
[794299]
Integra received notice that the device was used in a surgical procedure in 2005. As a result, pt injury has been alleged. This incident is being further investigated.
Patient Sequence No: 1, Text Type: D, B5
[8092381]
The device involved in the reported incident is expected to be available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 8010219-2008-00001 |
MDR Report Key | 998851 |
Report Source | 00 |
Date Received | 2008-02-15 |
Date of Report | 2008-02-15 |
Date Mfgr Received | 2008-01-18 |
Date Added to Maude | 2008-02-21 |
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 | 0 |
Event Location | 0 |
Manufacturer Contact | LINDA GOODSTEIN |
Manufacturer Street | 311C ENTERPRISE DR |
Manufacturer City | PLAINSBORO NJ 08536 |
Manufacturer Country | US |
Manufacturer Postal | 08536 |
Manufacturer Phone | 6099362269 |
Manufacturer G1 | INTEGRA NEUROSCIENCES, LTD. |
Manufacturer Street | NEWBURY RD. |
Manufacturer City | ANDOVER HAMPSHIRE SP104DR |
Manufacturer Postal Code | SP104DR |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | SELECTOR INTEGRA USA |
Generic Name | NONE |
Product Code | LBK |
Date Received | 2008-02-15 |
Catalog Number | 1530000M3 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Implant Flag | N |
Date Removed | B |
Device Sequence No | 1 |
Device Event Key | 968644 |
Manufacturer | INTEGRA NEUROSCIENCES, LTD. |
Manufacturer Address | ANDOVER HAMPSHIRE |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2008-02-15 |