MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-09 for GPS III SINGLE KIT W/30ML ACDA N/A 800-1003A manufactured by Biomet Biologics.
[54311910]
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.
Patient Sequence No: 1, Text Type: N, H10
[54311911]
During a shoulder arthroscopy procedure, an unknown event occurred; it is indicated the blood platelet separation kit was involved. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[56829962]
This follow-up report is being filed to correct and relay additional information, which was unknown at the time of the initial medwatch. There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 1 states, "damage to blood vessels, hematoma, delayed wound healing and/or infection. " review of sterilization certification confirms device was sterilized in accordance with iso 11137-2.
Patient Sequence No: 1, Text Type: N, H10
[56829963]
During a shoulder arthroscopy procedure, a blood platelet separation kit was used. The patient subsequently developed an infection. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2016-03569 |
| MDR Report Key | 5939349 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-09 |
| Date of Report | 2016-09-08 |
| Date of Event | 2015-01-13 |
| Date Mfgr Received | 2016-09-08 |
| Device Manufacturer Date | 2014-10-29 |
| Date Added to Maude | 2016-09-09 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | 2016-008R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GPS III SINGLE KIT W/30ML ACDA |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2016-09-09 |
| Model Number | N/A |
| Catalog Number | 800-1003A |
| Lot Number | 402274 |
| ID Number | N/A |
| Device Expiration Date | 2016-12-31 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Life Threatening; 2. Other | 2016-09-09 |