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 |