MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-11-28 for GPS III SINGLE KIT W/30ML ACDA NIN/A 800-1003A manufactured by Biomet Orthopedics.
[60988425]
The product identification necessary to review manufacturing history was not provided. Current information is insufficient to permit a conclusion as to the cause of the event. This is one of two devices that may have been involved in the event.
Patient Sequence No: 1, Text Type: N, H10
[60988426]
Patient alleged the size of the needle was larger than expected and she sustained a laceration on her arm as a result.
Patient Sequence No: 1, Text Type: D, B5
[111246191]
This follow-up report is being submitted to relay additional information. Reported event was unable to be confirmed due to limited information received from the customer. Review of the complaint history determined that no further action is required as no were trends identified. A definite root cause cannot be determined with the information provided. 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 | 0001825034-2016-04886 |
| MDR Report Key | 6130945 |
| Report Source | CONSUMER |
| Date Received | 2016-11-28 |
| Date of Report | 2017-09-26 |
| Date of Event | 2016-11-21 |
| Date Mfgr Received | 2017-09-26 |
| Date Added to Maude | 2016-11-28 |
| 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 | GPS III SINGLE KIT W/30ML ACDA |
| Generic Name | SUPPLIES, BLOOD-BANK |
| Product Code | KSS |
| Date Received | 2016-11-28 |
| Model Number | NIN/A |
| Catalog Number | 800-1003A |
| Lot Number | NI |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET ORTHOPEDICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-11-28 |