MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-11-19 for ANGEL CPRP PROCESSING SET US ABS-10063 manufactured by Arthrex, Inc..
[127678926]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[127678927]
It was reported that the abs-10063, angel cprp processing set leaked from the tubing during processing onto the table. Additional information has been requested. Update 11/19/18: numerous attempts have been made to obtain additional information from the reporter who it has been discovered is no longer affiliated with the facility. Facility is attempting to obtain and provide additional information; however, at this time, the facility has no additional information to provide.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00760 |
| MDR Report Key | 8086192 |
| Report Source | USER FACILITY |
| Date Received | 2018-11-19 |
| Date of Report | 2018-11-19 |
| Date of Event | 2018-10-30 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-19 |
| 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 | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL CPRP PROCESSING SET US |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2018-11-19 |
| Model Number | ANGEL CPRP PROCESSING SET US |
| Catalog Number | ABS-10063 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-11-19 |