MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-08-29 for SPF-PLUS 60/M N/A 10-1398M manufactured by Ebi, Llc..
[83844351]
(b)(4). The device currently remains implanted, therefore no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[83844352]
The patient called seeking information about the recall (zfa 2017-245). She reported she is experiencing itching that feels like it is coming from inside and redness at the surgical site, as well as headaches. She said her physician recommended leaving the stimulator in until her next appointment on (b)(6) 2017 because he felt like it was working well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2017-00041 |
| MDR Report Key | 6826454 |
| Report Source | CONSUMER |
| Date Received | 2017-08-29 |
| Date of Report | 2017-08-29 |
| Date Mfgr Received | 2017-08-03 |
| Device Manufacturer Date | 2017-01-18 |
| Date Added to Maude | 2017-08-29 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| 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 | SPF-PLUS 60/M |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2017-08-29 |
| Model Number | N/A |
| Catalog Number | 10-1398M |
| Lot Number | N/A |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2019-01-18 |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2017-08-29 |