MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-10-08 for LEAD END CAP KIT 5867-3M manufactured by Mpri.
| Report Number | 2649622-2019-18325 |
| MDR Report Key | 9166989 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-10-08 |
| Date of Report | 2019-10-08 |
| Date of Event | 2019-09-19 |
| Date Mfgr Received | 2019-09-19 |
| Device Manufacturer Date | 2016-07-21 |
| Date Added to Maude | 2019-10-08 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MPRI |
| Manufacturer Street | ROAD 149 KM 56.3 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD END CAP KIT |
| Generic Name | ADAPTOR, LEAD, PACEMAKER |
| Product Code | DTD |
| Date Received | 2019-10-08 |
| Model Number | 5867-3M |
| Catalog Number | 5867-3M |
| Lot Number | VA18DZK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MPRI |
| Manufacturer Address | ROAD 149 KM 56.3 VILLALBA PR 00766 US 00766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 419488 | 1. Hospitalization; 2. Required No Informationntervention | 2019-10-08 |