MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-06-15 for STANDARD GPS 6 PACK N/A 800-1006A manufactured by Biomet Biologics.
[47434302]
Current information is insufficient to permit a conclusion as to the cause of the event. Review of device history records show that lot released with no recorded anomaly or deviation. There are warnings in the package insert that state that this type of event can occur: under warnings and precautions, "do not use sterile components in this kit if package is opened or damaged. "
Patient Sequence No: 1, Text Type: N, H10
[47434303]
During a prp injection procedure, a particle of unknown material fell out of the device when being prepared for use. Another device was used to complete the procedure without delay.
Patient Sequence No: 1, Text Type: D, B5
[52013262]
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch. Examination of returned device found no evidence of product non-conformance. Review of the device was unable to confirm the reported complaint. A conclusive root cause of the event could not be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2016-02062 |
| MDR Report Key | 5726018 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-06-15 |
| Date of Report | 2016-07-15 |
| Date of Event | 2016-04-27 |
| Date Mfgr Received | 2016-07-15 |
| Device Manufacturer Date | 2016-03-04 |
| Date Added to Maude | 2016-06-15 |
| 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 | MS. MEGAN HAAS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743726700 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. 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 | STANDARD GPS 6 PACK |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2016-06-15 |
| Returned To Mfg | 2016-05-26 |
| Model Number | N/A |
| Catalog Number | 800-1006A |
| Lot Number | 600380 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2016-06-15 |