MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study,user facility report with the FDA on 2017-07-26 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc..
[80997936]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[80997937]
Tmr procedure performed on (b)(6) 2017. [patient] was transferred to [hospital] on (b)(6) 2017 from his rehab center due to a syncopal episode. He had a head ct done which found? Significant interim enlargement of left hemispheric subdural hematoma compared to prior study.? Of note, he had a pacemaker placed on (b)(6) 2017 and had the device checked on (b)(6) 2017 when he was admitted. The device was functioning normally. There was a neuro consult completed to evaluate the subdural hematoma. Under the care of neuro, patient had a left frontoparietal craniotomy for evaluation of the subdural hematoma. Following surgery, the patient has had improved neurological exam. As of today, patient is still admitted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2017-00024 |
| MDR Report Key | 6743325 |
| Report Source | STUDY,USER FACILITY |
| Date Received | 2017-07-26 |
| Date of Report | 2017-09-20 |
| Date of Event | 2017-06-21 |
| Date Facility Aware | 2017-06-26 |
| Date Mfgr Received | 2017-06-26 |
| Date Added to Maude | 2017-07-26 |
| 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 | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| 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 | 2017-07-26 |
| Model Number | HP-SG3 |
| Catalog Number | HP-SG3 |
| Lot Number | TA-04099 |
| Operator | PHYSICIAN |
| 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. Other | 2017-07-26 |