MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-04 for DIRECTLINK ICP MODULE 826828 manufactured by Integra Lifesciences Switzerland Sar.
| Report Number | 1226348-2019-00516 |
| MDR Report Key | 9273024 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-04 |
| Date of Report | 2019-10-15 |
| Date of Event | 2019-11-15 |
| Date Mfgr Received | 2019-10-15 |
| Date Added to Maude | 2019-11-04 |
| 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 | MRS. VIVIAN NELSON |
| Manufacturer Street | RUE GIRARDET 29 CH-2400 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Manufacturer G1 | INTEGRA LIFESCIENCES SWITZERLAND SAR |
| Manufacturer Street | RUE GIRARDET 29 CH-2400 |
| Manufacturer City | LE LOCLE |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIRECTLINK ICP MODULE |
| Generic Name | DIRECTLINK - MODULE |
| Product Code | GWM |
| Date Received | 2019-11-04 |
| Catalog Number | 826828 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES SWITZERLAND SAR |
| Manufacturer Address | RUE GIRARDET 29 RUE GIRARDET 29 LE LOCLE SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-04 |