MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-04 for BIOMET EBI BONE HEALING SYSTEM N/A 1068234 manufactured by Ebi, Llc..
[188861577]
Zimmer biomet complaint (b)(4). Date of event: the event occurred sometime in (b)(6) 2019. The customer has indicated that the product will not be returned to zimmer biomet for investigation as the device is still being used. The investigation is in process. 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
[188861578]
It was reported that the patient was experiencing pain from using the bone healing system (bhs). The patient got the bhs for her right foot. The patient stated that the pain felt like an intense throbbing. The patient rated the pain a 9 or 10 on a scale of 1 to 10, with 10 being the worst. The patient stated that the pain was the most intense while she slept; it would wake her out of her sleep. When the patient wears the bhs during the day the pain is no where near as intense as when she sleeps. There are no marks on her skin. The patient did speak to her doctor who said that they had never heard anything like this before. The patient is now wearing the device only during the day. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2020-00015 |
| MDR Report Key | 9664200 |
| Report Source | CONSUMER |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-03 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-04 |
| 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 | BIOMET EBI BONE HEALING SYSTEM |
| Generic Name | STIMULATOR, BONE GROWTH, NON-INVASIVE |
| Product Code | LOF |
| Date Received | 2020-02-04 |
| Model Number | N/A |
| Catalog Number | 1068234 |
| Lot Number | N/A |
| 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 | 2020-02-04 |