MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-29 for ARTHREX ANGEL SSYTEM ABS-10060 manufactured by Arthrex.
[87860782]
During surgical procedure, md put aspirated blood product in machine for "spinning". Product exploded. Cartridge came apart twice. Rep present during case. Dates of use: (b)(6) 2017. Diagnosis or reason for use: arthrodesis. Is the product compounded: no. Is the product over-the-counter: no. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072524 |
| MDR Report Key | 6903576 |
| Date Received | 2017-09-29 |
| Date of Report | 2017-09-15 |
| Date of Event | 2017-08-16 |
| Date Added to Maude | 2017-09-29 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARTHREX ANGEL SSYTEM |
| Generic Name | ANGEL PROCESSING KIT |
| Product Code | JQC |
| Date Received | 2017-09-29 |
| Returned To Mfg | 2017-08-17 |
| Model Number | ABS-10060 |
| Lot Number | 2016120049 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-09-29 |