MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-17 for SOLOGRIP III HANDPIECE HP-SG3 manufactured by Cryolife, Inc. ? Kennesaw.
[123969936]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[123969937]
According to initial reports from (b)(6) study, patient was hospitalized from (b)(6) 2017 for atrial flutter and adhf. Patient impact: on (b)(6) 2017: rehospitalization due to heart failure; congestive heart failure; ventricular arrhythmia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2018-00042 |
| MDR Report Key | 7973539 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-17 |
| Date of Report | 2018-12-17 |
| Date of Event | 2018-10-11 |
| Date Facility Aware | 2018-09-18 |
| Date Mfgr Received | 2018-09-18 |
| Date Added to Maude | 2018-10-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD |
| 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 | LASER THERAPY PRODUCT |
| Product Code | MNO |
| Date Received | 2018-10-17 |
| Model Number | HP-SG3 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? KENNESAW |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Brand Name | SOLOGRIP III HANDPIECE |
| Generic Name | LASER THERAPY PRODUCT |
| Product Code | RHL |
| Date Received | 2018-10-17 |
| Model Number | HP-SG3 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. ? KENNESAW |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2018-10-17 |