MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-21 for BIOMET EBI BONE HEALING SYSTEM SFLX 2-4 COIL N/A 1068228 manufactured by Ebi, Llc..
[188255960]
(b)(4). Date of event: the event occurred sometime in (b)(6) 2019. Concomitant medical product: biomet ebi bone healing system - catalog: #1068234 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
[188255961]
It was reported that the patient was becoming sore from using the bone healing system (bhs) sflx 2-4 coil. The patient got the bhs for his left foot and was wearing the coil under his boot. The patient stated that when he removed the sflx 2-4 coil, it looked like there was a hole in his foot about 1 inch deep where the ankle meets the foot and another hole about the size of a dime on his big toe. The patient saw the doctor and was prescribed mupirocin ointment. The redness has since calmed down and the doctor wants the patient to switch to a different device for treatment. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2020-00009 |
| MDR Report Key | 9610232 |
| Report Source | CONSUMER |
| Date Received | 2020-01-21 |
| Date of Report | 2020-04-01 |
| Date Mfgr Received | 2020-03-27 |
| Date Added to Maude | 2020-01-21 |
| 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 SFLX 2-4 COIL |
| Generic Name | STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL) |
| Product Code | LOF |
| Date Received | 2020-01-21 |
| Model Number | N/A |
| Catalog Number | 1068228 |
| 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 | 2020-01-21 |