MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-12-18 for ANGEL CPRP PROCESSING SET US ABS-10063 manufactured by Arthrex, Inc..
[131052189]
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
[131052190]
It was reported by the sales rep, that 4 minutes into the spin for a prp injection of the achilles there was a loud noise and the disk inside the abs-10060r snapped in half spilling the blood into the disk. The prp injection was not completed. Additional information obtained (b)(6) 2018: this occurred during a surgical procedure for a patient with achilles tendinopathy. The prp was to be injected following tendon debridement. The patient's blood did not come into contact with anyone. The blood was contained in the separation chamber of the angel machine. The blood was initially dried up with surgical towels and then with facility provided germicidal wipes. There was no picture taken of the blood spilled inside the separation chamber. Sales rep was present during this procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00806 |
| MDR Report Key | 8174694 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-12-18 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-11-21 |
| Date Mfgr Received | 2018-11-21 |
| Device Manufacturer Date | 2018-05-23 |
| Date Added to Maude | 2018-12-18 |
| 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 | 2018-12-18 |
| Model Number | ANGEL CPRP PROCESSING SET US |
| Catalog Number | ABS-10063 |
| Lot Number | 2018020008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-12-18 |