MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-17 for ELECTRODES, LT-4500 N/A 106130-12 manufactured by Ebi, Llc..
[183720485]
Date of event: the event occurred sometime in (b)(6) 2020. Concomitant medical product: orthopak assembly: catalog: #1067718, serial: # (b)(4). Therapy date: unknown. Concomitant medical product: smith & nephew taylor spatial frame. Therapy date: (b)(6) 2019. The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2020-00028.
Patient Sequence No: 1, Text Type: N, H10
[183720486]
It was reported that the patient experienced skin irritation from the 72r and lt-4500 electrodes. The patient described the skin as red and itchy with blisters and welts. Initially, the irritation was strictly under the electrodes but the irritation began to spread. The patient did contact the surgeon regarding the skin irritation. The surgeon advised the patient to stop using the unit and prescribed an ointment. It was reported that no further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2020-00029 |
| MDR Report Key | 9841673 |
| Report Source | CONSUMER |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-02-25 |
| Date Added to Maude | 2020-03-17 |
| 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 | SARA DAILEY |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer G1 | EBI, LLC. |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTRODES, LT-4500 |
| Generic Name | ELECTRODES |
| Product Code | LOF |
| Date Received | 2020-03-17 |
| Model Number | N/A |
| Catalog Number | 106130-12 |
| Lot Number | 913014 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC. |
| Manufacturer Address | 399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-17 |