MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-08-14 for GPS III PLATELET CONCENTRATE SEPARATION KIT/SINGLE DISPOSABLE 30ML ACD-A N/A 800-0505A manufactured by Biomet Biologics.
[2860981]
It was reported patient underwent a plantar fascia injection on (b)(6) 2012. During the procedure, a gps mini kit was opened and the buoy was elevated from the normal position at the base of the gps tube prior to centrifugation. Another kit was used to complete the procedure. No patient injury or surgical delay occurred.
Patient Sequence No: 1, Text Type: D, B5
[10026413]
Examination of returned device was inconclusive. Review of device history records show that lot released with no recorded anomaly or deviation. The user facility was notified of the event. In the event that the user facility submits a medwatch report, biomet will forward a copy to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2012-01281 |
| MDR Report Key | 2696149 |
| Report Source | 07 |
| Date Received | 2012-08-14 |
| Date of Report | 2012-07-25 |
| Date of Event | 2012-06-18 |
| Date Mfgr Received | 2012-07-25 |
| Device Manufacturer Date | 2012-03-20 |
| Date Added to Maude | 2012-12-03 |
| 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. ANGIE 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 PLATELET CONCENTRATE SEPARATION KIT/SINGLE DISPOSABLE 30ML ACD-A |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2012-08-14 |
| Returned To Mfg | 2012-07-03 |
| Model Number | N/A |
| Catalog Number | 800-0505A |
| Lot Number | 200802 |
| ID Number | N/A |
| Device Expiration Date | 2014-11-30 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET BIOLOGICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-14 |