MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-04-10 for SHELHIGH VASCUPATCH SHP-555-CRT17 manufactured by Shelhigh.
[19956608]
Male pt underwent left carotid endarterectomy procedure using a shelhigh vasupatch for closure. Hosp reports that pt developed an infection at graft site. Pt had readmission and returned to or and died in 2006. Incident occurred the same year. Hosp did not provide notification to shelhigh at the time of incident. Hosp only submitted a medwatch report several months after the incident. Limited info was provided at that time.
Patient Sequence No: 1, Text Type: D, B5
[20085058]
Shelhigh (mfr of the vascupatch) became aware of this event as a result of receiving an fda medwatch report. The user facility reported the event only to fda (approx 8 months after incident). Explanted device was not returned to shelhigh for examination. Details of any pathological eval was not provided by hosp. Cultures that may have been conducted were not provided. The info regarding this incident is insufficient to conduct an investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247123-2007-00002 |
| MDR Report Key | 840597 |
| Report Source | 00 |
| Date Received | 2007-04-10 |
| Date of Report | 2007-04-09 |
| Date Mfgr Received | 2007-04-02 |
| Date Added to Maude | 2007-04-25 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 650 LIBERTY AVE |
| Manufacturer City | UNION NJ 07083 |
| Manufacturer Country | US |
| Manufacturer Postal | 07083 |
| Manufacturer Phone | 9082068706 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHELHIGH VASCUPATCH |
| Generic Name | PERICARDIAL PATCH GRAFT |
| Product Code | MFX |
| Date Received | 2007-04-10 |
| Model Number | SHP-555-CRT17 |
| Catalog Number | SHP-555-CRT17 |
| Lot Number | NOT AVAILABLE |
| ID Number | * |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 811431 |
| Manufacturer | SHELHIGH |
| Manufacturer Address | * UNION NJ * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-04-10 |