MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-29 for PUMP MMT-1780KPK 670G PATHWAY BLACK MG manufactured by Medtronic Puerto Rico Operations Co..
Report Number | 2032227-2019-125309 |
MDR Report Key | 9391585 |
Report Source | CONSUMER |
Date Received | 2019-11-29 |
Date of Report | 2019-11-29 |
Date of Event | 2019-09-16 |
Date Mfgr Received | 2019-11-26 |
Device Manufacturer Date | 2018-06-28 |
Date Added to Maude | 2019-11-29 |
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 | GERWIN DE GRAAFF |
Manufacturer Street | CEIBA NORTE IND. PARK #50 ROAD |
Manufacturer City | JUNCOS 00777-386 |
Manufacturer Postal | 00777-3869 |
Manufacturer Phone | 8185464805 |
Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS CO. |
Manufacturer Street | CEIBA NORTE IND. PARK #50 ROAD |
Manufacturer City | JUNCOS 00777-386 |
Manufacturer Postal Code | 00777-3869 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | PUMP MMT-1780KPK 670G PATHWAY BLACK MG |
Generic Name | ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL |
Product Code | OZP |
Date Received | 2019-11-29 |
Returned To Mfg | 2019-10-04 |
Model Number | MMT-1780KPK |
Catalog Number | MMT-1780KPK |
Lot Number | HG2MZA3 |
Operator | LAY USER/PATIENT |
Device Availability | R |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
Manufacturer Address | CEIBA NORTE IND. PARK #50 ROAD JUNCOS 00777-386 00777-3869 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2019-11-29 |