MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-06-14 for BIOMET BIOLOGICS COUNTERBALANCE N/A 800-0508 manufactured by Biomet Biologics.
[77502492]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Product device code = jqo.
Patient Sequence No: 1, Text Type: N, H10
[77502493]
It was reported that during a procedure utilizing a gps kit, the counter balance water tube broke during centrifugation. A new counterbalance was placed in the centrifuge and the blood was spun to complete the procedure, after delaying procedure for forty-five (45) minutes. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[109783499]
This follow-up report is being submitted to relay additional information. Upon reassessment of the reported event, it was determined to be not reportable as there was no patient injury nor harm. The initial report was filed in error and should be voided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-03847 |
| MDR Report Key | 6639465 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-14 |
| Date of Report | 2017-08-22 |
| Date Mfgr Received | 2017-08-21 |
| Date Added to Maude | 2017-06-14 |
| 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. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| 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 | BIOMET BIOLOGICS COUNTERBALANCE |
| Product Code | JQO |
| Date Received | 2017-06-14 |
| Model Number | N/A |
| Catalog Number | 800-0508 |
| Lot Number | 125033 |
| ID Number | N/A |
| 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. Hospitalization | 2017-06-14 |