MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-07 for NEURO BALLOON CATHETER 7CBD10 manufactured by Integra Neurosciences Implants S.a..
| Report Number | 9612007-2019-00030 |
| MDR Report Key | 8678366 |
| Date Received | 2019-06-07 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-05-14 |
| Date Mfgr Received | 2019-07-12 |
| Device Manufacturer Date | 2018-10-11 |
| Date Added to Maude | 2019-06-07 |
| 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 KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
| Manufacturer Street | 2905 ROUTE DES DOLINES |
| Manufacturer City | SOPHIA ANTIPOLIS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEURO BALLOON CATHETER |
| Generic Name | NEUROENDOSCOPY |
| Product Code | HAO |
| Date Received | 2019-06-07 |
| Returned To Mfg | 2019-07-04 |
| Catalog Number | 7CBD10 |
| Lot Number | 0210847 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES IMPLANTS S.A. |
| Manufacturer Address | 2905 ROUTE DES DOLINES 2905 ROUTE DES DOLINES SOPHIA ANTIPOLIS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-07 |