MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-08-27 for SJM PERICARDIAL PATCH WITH ENCAP AC TECHNOLOGY C0405 manufactured by St. Jude Medical, Inc..
| Report Number | 3007113487-2019-00023 |
| MDR Report Key | 8937491 |
| Date Received | 2019-08-27 |
| Date of Report | 2019-11-15 |
| Date of Event | 2019-07-19 |
| Date Mfgr Received | 2019-11-08 |
| Date Added to Maude | 2019-08-27 |
| 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 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | PAMELA YIP |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | GLYCAR S.A. (PTY.) LTD. |
| Manufacturer Street | 1 ALBERT RD |
| Manufacturer City | IRENE MN 0062 |
| Manufacturer Country | SF |
| Manufacturer Postal Code | 0062 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SJM PERICARDIAL PATCH WITH ENCAP AC TECHNOLOGY |
| Generic Name | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
| Product Code | DXZ |
| Date Received | 2019-08-27 |
| Returned To Mfg | 2019-08-26 |
| Model Number | C0405 |
| Catalog Number | C0405 |
| Lot Number | T1810303 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 177 EAST COUNTY ROAD B ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2019-08-27 |