MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-21 for SPF-XL IIB 2/DM N/A 10-1335M manufactured by Ebi, Llc..
[145646564]
(b)(4). Concomitant medical products- percocet, zetia, amitriptyline, tizanidine, centrum, probiotics. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once he investigation is completed, a supplemental medwatch 35000a will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[145646565]
It was reported that the patient experienced symptoms of nerve pain, chronic pain, swelling, inflammation and also infection. The patient had the spf device implanted for 12 years. The patient also stated that she had urine problems, could not empty her bladder, and had to use antibiotic for pain. The patient stated that no physician would remove the device. The patient stated that she had the device removed earlier this year by a pain management doctor. The patient stated that after explanation of the device, the infections and horrible pain cleared, and the ability to live is coming back. The patient indicated that she continues to use antibiotics and that she is going to pain management. The patient wanted to know whether there was a recall on the spf model that she was treated with. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00016 |
| MDR Report Key | 8627837 |
| Report Source | CONSUMER |
| Date Received | 2019-05-21 |
| Date of Report | 2019-05-14 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-05-01 |
| Date Added to Maude | 2019-05-21 |
| 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 | SHAAN POLIUS |
| 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-XL IIB 2/DM |
| Generic Name | EBI SPF-XL IIB BONE GROWTH STIMULATOR |
| Product Code | LOE |
| Date Received | 2019-05-21 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| 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; 2. Deathisabilit | 2019-05-21 |