MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-23 for SOFT-TOUCH ELECTRODES, 63B N/A 106130-22 manufactured by Ebi, Llc..
[188860914]
Zimmer biomet complaint (b)(4). Date of event: the event occurred sometime in (b)(6) 2020. Medical product: spinalpak assembly catalog: #1066716 serial: # (b)(4). Therapy date: unknown. 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: 0002242816-2020-00010. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[188860915]
It was reported that the patient experienced skin irritation from using the 63b electrodes and the cover patches on his lower back. The patient stated that he did not have any pain, the skin was just very itchy. The skin became very raw and would bleed. The patient did contact his doctor who advised the patient to discontinue use of the unit. The patient reported that since he stopped using the device all that he has left is a little bit of a scab. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2020-00011 |
| MDR Report Key | 9621514 |
| Report Source | CONSUMER |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-23 |
| Date Mfgr Received | 2020-01-06 |
| Date Added to Maude | 2020-01-23 |
| 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 | SOFT-TOUCH ELECTRODES, 63B |
| Generic Name | ELECTRODES |
| Product Code | LOF |
| Date Received | 2020-01-23 |
| Model Number | N/A |
| Catalog Number | 106130-22 |
| 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 | 2020-01-23 |