MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-12-16 for SOFT-TOUCH ELECTRODES, 63B N/A 106130-22 manufactured by Ebi, Llc..
[182724381]
Zimmer biomet complaint (b)(4). Medical product: spinalpak assembly: catalog #1067716, 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.
Patient Sequence No: 1, Text Type: N, H10
[182724382]
It was reported that the patient was experiencing skin irritation from the 63b electrodes. The patient has been using the 63b electrodes for several months and said that the new batch was causing skin irritation. The patient has been using hydrocortisone cream on the skin irritation. The patient contacted the doctor's office and was advised to stop wearing the unit until the skin is completely healed. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00051 |
| MDR Report Key | 9475504 |
| Report Source | CONSUMER |
| Date Received | 2019-12-16 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-18 |
| Date Added to Maude | 2019-12-16 |
| 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 | 2019-12-16 |
| 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 | 2019-12-16 |