MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2014-03-25 for OJEMAN CORTICAL STIMULATOR OCS2 manufactured by Integra Burlington, Ma, Inc.
[19795614]
To date, the device involved in the reported incident has not be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
[19797929]
The product was not stimulating. No other info was provided. Several attempts have been made to obtain info but to date, no new info has been received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222895-2014-00005 |
| MDR Report Key | 3815919 |
| Report Source | 01 |
| Date Received | 2014-03-25 |
| Date of Report | 2014-03-06 |
| Date Mfgr Received | 2014-03-20 |
| Date Added to Maude | 2014-06-13 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OJEMAN CORTICAL STIMULATOR |
| Generic Name | NA |
| Product Code | GYC |
| Date Received | 2014-03-25 |
| Catalog Number | OCS2 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON, MA, INC |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-25 |