MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-13 for SOFT-TOUCH ELECTRODES, 63B N/A 106130-22 manufactured by Ebi, Llc..
[188195809]
(b)(4). The customer has indicated that the product will not be returned to zimmer biomet for investigation. The patient is still using the electrodes. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Concomitant medical product: spinalpak assembly catalog no: 1067716 serial no: (b)(4). Therapy date: unknown. Concomitant: medical product: 7. 0 x 50 mm screws - in the sacrum. Concomitant medical product: depuy bullet cage 8 mm x 27 mm. Concomitant medical product: #10 blake drain. Therapy date: (b)(6) 2019. Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2020-00004, 0002242816-2020-00006. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[188195810]
It was reported that the patient experienced skin irritation from the electrodes. The patient said that the skin was red, itchy, and developed welts. The patient saw their surgeon for the irritation and was told to continue using them and to reach out to a dermatologist. The patient saw their dermatologist and was diagnosed with a skin disorder. The patient continued using the electrodes and tried changing them every day. Initially, it worked but the skin irritation came back. The patient called their primary physician and was prescribed fluocinonide 0. 05% cream. The cream cleared the irritation. Upon using the electrodes again, the skin irritation developed within half a day. The patient reached out to their surgeon again and was told to keep using the unit. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2020-00005 |
| MDR Report Key | 9581545 |
| Report Source | CONSUMER |
| Date Received | 2020-01-13 |
| Date of Report | 2020-02-11 |
| Date Mfgr Received | 2020-02-11 |
| Date Added to Maude | 2020-01-13 |
| 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 | 2020-01-13 |
| Model Number | N/A |
| Catalog Number | 106130-22 |
| Lot Number | UNK |
| 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 | 2020-01-13 |