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, 72R N/A 106130-20 manufactured by Ebi, Llc..
[174670718]
(b)(4). Concomitant medical product: spinalpak assembly, catalog no: 1067716, serial no: (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. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[174670719]
It was reported that the patient developed skin irritation from the 72r electrodes. The patient was applying the electrodes on the thoracic and lumbar area. The patient stated that their skin was red, itchy and it stung. The patient developed welts and blisters that oozed. The patient called her surgeon's office and was told to stop wearing the electrodes until the blisters were healed. The patient stated that it took over a week for her skin to clear. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2020-00002 |
| MDR Report Key | 9580339 |
| Report Source | CONSUMER |
| Date Received | 2020-01-13 |
| Date of Report | 2020-02-19 |
| Date Mfgr Received | 2020-02-14 |
| Device Manufacturer Date | 2019-06-04 |
| 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, 72R |
| Generic Name | ELECTRODES |
| Product Code | LOF |
| Date Received | 2020-01-13 |
| Returned To Mfg | 2020-02-13 |
| Model Number | N/A |
| Catalog Number | 106130-20 |
| Lot Number | 912339 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 |