MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-12-05 for ELECTRODE COVER PATCHES N/A 106130-17 manufactured by Ebi, Llc..
[169205721]
(b)(4). Date of event: the event occurred sometime in (b)(6) 2019. Concomitant medical product: spinalpak assembly: serial # (b)(4), catalog #1067716. Therapy date: unknown. 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. Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2019-00043, 0002242816-2019-00045, 0002242816-2019-00046. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[169205722]
It was reported that the patient experienced skin irritation from using the electrodes and cover patches for the spinalpak. The patient said that the skin was red and itchy with little bumps and scabs. The patient said that the skin irritation was painful. The patient tried to break up her treatment time and use different electrodes but the skin irritation still occurred. The patient contacted her doctor who advised her to stop using the spinalpak. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00044 |
| MDR Report Key | 9415367 |
| Report Source | CONSUMER |
| Date Received | 2019-12-05 |
| Date of Report | 2020-03-17 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-03-25 |
| Date Added to Maude | 2019-12-05 |
| 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 | 2019-12-05 |
| Model Number | N/A |
| Catalog Number | 106130-17 |
| Lot Number | 909501 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-05 |