MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-27 for CPT, PACEMAKER PACK (PPSHC)606 SCVHFPPSHD manufactured by Mex03 Mexico-juarez Presource.
| Report Number | 1423537-2020-00433 |
| MDR Report Key | 9765203 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-27 |
| Date of Report | 2020-03-26 |
| Date of Event | 1980-01-01 |
| Date Mfgr Received | 2020-01-30 |
| Device Manufacturer Date | 2019-10-11 |
| Date Added to Maude | 2020-02-27 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8478874151 |
| Manufacturer G1 | MEX03 MEXICO-JUAREZ PRESOURCE |
| Manufacturer Street | C. ARCADIA 1580 , COL. TERRAZA |
| Manufacturer City | CD.JUAREZ , CHIHUAHUA CP 32599 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | CP 32599 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CPT, PACEMAKER PACK (PPSHC)606 |
| Generic Name | CARDIOVASCULAR PROCEDURE KIT |
| Product Code | OEZ |
| Date Received | 2020-02-27 |
| Model Number | SCVHFPPSHD |
| Catalog Number | SCVHFPPSHD |
| Lot Number | 328121 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEX03 MEXICO-JUAREZ PRESOURCE |
| Manufacturer Address | C. ARCADIA 1580 , COL. TERRAZA CD.JUAREZ , CHIHUAHUA CP 32599 MX CP 32599 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-27 |