MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-06-17 for BLV/BIS 4403 manufactured by Oscor Inc..
| Report Number | 1035166-2019-00052 |
| MDR Report Key | 8704472 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-06-17 |
| Date of Report | 2019-08-27 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2019-08-27 |
| Device Manufacturer Date | 2010-04-02 |
| Date Added to Maude | 2019-06-17 |
| 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 | MR. DOUG MYERS |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 34683 |
| Manufacturer Country | US |
| Manufacturer Postal | 34683 |
| Manufacturer Phone | 7279372511 |
| Manufacturer G1 | OSCOR INC. |
| Manufacturer Street | 3816 DESOTO BLVD. |
| Manufacturer City | PALM HARBOR FL 34683 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 34683 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BLV/BIS 4403 |
| Generic Name | PACEMAKER LEAD ADAPTOR |
| Product Code | DTD |
| Date Received | 2019-06-17 |
| Model Number | 4403 |
| Catalog Number | 4403 |
| Lot Number | C2-11508 |
| Device Expiration Date | 2013-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSCOR INC. |
| Manufacturer Address | 3816 DESOTO BLVD. PALM HARBOR FL 34683 US 34683 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-06-17 |