MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-03 for PROCOL * HJL016-30-N manufactured by Hancock Jaffe Laboratories.
[383696]
Initially, problem identified as a possible product problem. Pt status post dialysis graft placement 2 weeks. Presented to emergency room in full arrest, bleeding from right upper arm. Pt successfully resuscitated. Surgeon notified and opened right upper arm. Graft had hole in it-not near graft anastomosis site. Surgeon ligated graft. Pt to dialysis and then to the acute observation unit. During conversation with nephrologist dir of nursing and the cousin of pt, cousin stated that the pt phoned them and told them they had fallen and were bleeding like a "hog. " rptr was unaware of fall unitl this time. Blood alcohol level 20 - drawn several hours after arrival to emergency room. Device available now. Intent to return to mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034295 |
| MDR Report Key | 565967 |
| Date Received | 2005-01-03 |
| Date of Report | 2005-01-03 |
| Date of Event | 2004-12-29 |
| Date Added to Maude | 2005-01-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROCOL |
| Generic Name | VASCULAR BIOPROSTHESIS |
| Product Code | FIQ |
| Date Received | 2005-01-03 |
| Model Number | * |
| Catalog Number | HJL016-30-N |
| Lot Number | SB011040 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 555755 |
| Manufacturer | HANCOCK JAFFE LABORATORIES |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2005-01-03 |