MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-03 for PROCOL VASCULAR BIOPROSTHESIS HJL016-25-N manufactured by Hancock Jaffe Laboratories.
[30329427]
This physician experienced two cases of postoperative infection by the same organism within a short time period. The manufacturer's investigation showed that the device was sterile at the time of delivery and was unlikely to be the source of the contamination. This is most likely a hospital surgical or post surgical infection and the physician is conducting an investigation of staff and facility to identify a source.
Patient Sequence No: 1, Text Type: N, H10
[30329428]
On (b)(6) 2015 a procol graft was implanted in the left arm of a female patient for av-access. Approximately 4 weeks later the patient presented with cellulitis over the graft and drainage from the incision above the elbow. A specimen was collected for culturing and the patient was prescribed oral antibiotics and sent home. The culture confirmed the presence of infection (staphylococcus aureus) and when the patient had not responded to the antibiotics after 72 hours the graft was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008142729-2015-00002 |
| MDR Report Key | 5199320 |
| Date Received | 2015-11-03 |
| Date of Report | 2015-10-30 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2015-10-20 |
| Device Manufacturer Date | 2014-08-20 |
| Date Added to Maude | 2015-11-03 |
| 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 | MS. SUE MONTOYA |
| Manufacturer Street | 70 DOPPLER |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9492612900 |
| Manufacturer G1 | HANCOCK JAFFE LABORATORIES |
| Manufacturer Street | 70 DOPPLER |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PROCOL VASCULAR BIOPROSTHESIS |
| Generic Name | VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2015-11-03 |
| Model Number | HJL016-25-N |
| Catalog Number | HJL016-25-N |
| Device Expiration Date | 2019-01-26 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HANCOCK JAFFE LABORATORIES |
| Manufacturer Address | 70 DOPPLER IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2015-11-03 |