MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-25 for GPS III KIT N/A 800-0505A manufactured by Biomet Biologics.
[19997278]
It was reported that a procedure was performed utilizing a platelet separation system on (b)(6), 2012. As the technician was trying to remove air from the syringe containing the acd-a solution, the solution discharged into her eyes. The technician flushed her eyes with water for ten minutes, but experienced redness and irritation throughout the following day.
Patient Sequence No: 1, Text Type: D, B5
[20208988]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of receiving certificate of conformance showed that lot released with no recorded anomaly or deviation. This report is number 1 of 2 mdrs filed for the same event (reference 1216032-2012-00001).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-00683 |
| MDR Report Key | 2589213 |
| Report Source | 05 |
| Date Received | 2012-05-25 |
| Date of Report | 2012-05-10 |
| Date of Event | 2012-05-10 |
| Date Mfgr Received | 2012-05-10 |
| Device Manufacturer Date | 2011-10-08 |
| Date Added to Maude | 2012-05-25 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. ANGELA DICKSON |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743711021 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 EAST BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GPS III KIT |
| Generic Name | HEMATOLOGY PRODUCT |
| Product Code | JPK |
| Date Received | 2012-05-25 |
| Model Number | N/A |
| Catalog Number | 800-0505A |
| Lot Number | 112904 |
| ID Number | N/A |
| Device Expiration Date | 2014-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET BIOLOGICS |
| Manufacturer Address | 56 EAST BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-25 |