MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-10-04 for CS100 N/A 0998-00-3013-45 manufactured by Datascope Corp. - Mahwah.
| Report Number | 2249723-2019-01601 |
| MDR Report Key | 9158618 |
| Date Received | 2019-10-04 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-08-27 |
| Date Mfgr Received | 2019-09-12 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2019-10-04 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 1300 MACARTHUR BLVD |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal | 07430 |
| Manufacturer G1 | DATASCOPE CORP. - MAHWAH |
| Manufacturer Street | 1300 MACARTHUR BLVD |
| Manufacturer City | MAHWAH NJ 07430 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07430 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CS100 |
| Generic Name | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) |
| Product Code | BSP |
| Date Received | 2019-10-04 |
| Model Number | N/A |
| Catalog Number | 0998-00-3013-45 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATASCOPE CORP. - MAHWAH |
| Manufacturer Address | 1300 MACARTHUR BLVD MAHWAH NJ 07430 US 07430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-04 |