MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-01 for ELECTRODE COVER PATCHES N/A 106130-17 manufactured by Ebi, Llc..
[164723238]
(b)(4). Customer has indicated that the product will not be returned to zimmer biomet for investigation because the patient no longer has any product to return. The investigation is in progress. Once the investigation has been completed, a follow-up mdr will be submitted. The event occurred sometime in (b)(6) 2019. Concomitant medical product: spinalpak assembly: catalog #1067716 serial #(b)(4). Therapy date: unknown. Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2019-00035.
Patient Sequence No: 1, Text Type: N, H10
[164723239]
It was reported that the patient developed a rash from using the 63b electrodes and the electrode cover patches. The patient stated that she had blisters and welts. The patient would change and reposition the electrodes and cover patches but would still develop the rash. The patient reported this to her doctor who advised that she remove the stimulator. The patient has stopped using the device. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00036 |
| MDR Report Key | 9266904 |
| Report Source | CONSUMER |
| Date Received | 2019-11-01 |
| Date of Report | 2019-11-01 |
| Date Mfgr Received | 2019-10-23 |
| Date Added to Maude | 2019-11-01 |
| 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 | ELECTRODE COVER PATCHES |
| Generic Name | COVER PATCHES |
| Product Code | LOF |
| Date Received | 2019-11-01 |
| Model Number | N/A |
| Catalog Number | 106130-17 |
| Lot Number | UNK |
| 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 | 2019-11-01 |