MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-16 for 4 CONTACT DEPTH ELECTRODE, 2.5 MM LENGTH, 5 MM SPACING AU4D5L25 manufactured by Integra Neuroscicencs Implants Sa.
[77844835]
It was reported that the packaging of the product was torn. The product was not in contact with patient. No patient injured or death alleged. The event did not lead to an increase of surgery time. The issue was discovered at receipt of the product by the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9612007-2017-00013 |
| MDR Report Key | 6648831 |
| Date Received | 2017-06-16 |
| Date of Report | 2017-05-22 |
| Date Mfgr Received | 2017-09-14 |
| Date Added to Maude | 2017-06-16 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Street | 2905 ROUTE DES DOLINES |
| Manufacturer City | SOPHIA ANTIPOLIS F-06921 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | F-06921 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 4 CONTACT DEPTH ELECTRODE, 2.5 MM LENGTH, 5 MM SPACING |
| Generic Name | DEPTH ELECTRODES |
| Product Code | GYC |
| Date Received | 2017-06-16 |
| Returned To Mfg | 2017-06-02 |
| Catalog Number | AU4D5L25 |
| Lot Number | 0199182 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCICENCS IMPLANTS SA |
| Manufacturer Address | 2905 ROUTE DES DOLINES 2905 ROUTE DES DOLINES SOPHIA ANTIPOLIS F-06921 FR F-06921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-16 |