MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2018-05-17 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[108616620]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[108616621]
According to an email on 04/18/218: "presented with 1 day history of chest pain described as pressure in the center of his chest radiating to his back consistent with previous episodes of angina. Patient stated he was eating at a restaurant and suddenly had (b)(6) chest pain. He complains of dizziness and nausea with two episodes of vomiting. Complained of epigastric pain as well. Pain was relieved with rest after onset. Serial troponins were negative. Slight tachycardia noted. Since the patient had a recent cardiac catheterization, no catheterization was done at this admission. Conservative medical management was deemed appropriate and patient's coreg was increased from 12. 5mg bid to 25 mg bid. Patient was discharged to home on (b)(6) 2017. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00017 |
| MDR Report Key | 7523781 |
| Report Source | STUDY |
| Date Received | 2018-05-17 |
| Date of Report | 2018-08-15 |
| Date of Event | 2017-05-03 |
| Date Facility Aware | 2018-04-18 |
| Date Mfgr Received | 2018-04-18 |
| Date Added to Maude | 2018-05-17 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD, NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLOGRIP III HANDPIECE |
| Generic Name | SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION |
| Product Code | MNO |
| Date Received | 2018-05-17 |
| Model Number | HP-SG3 |
| Catalog Number | HP-SG3 |
| Lot Number | TA-04093 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2018-05-17 |