MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-05-22 for SPF PLUS-MINI (60 ?A/W) N/A 10-1398M manufactured by Ebi, Llc..
[145757042]
(b)(4). Date of event: the event occurred sometime in (b)(6) 2019. The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[145757043]
It was reported that the patient had the spf implanted approximately 3 years after being implanted. The patient indicated that the device was explanted because it was not mri safe. She stated that spf did not cause her to feel well, and she experienced pain. The patient stated that she has had no quality of life for the past 3 years, and that the spf affected her immune system. The patient also indicated that she had a bone graft that never healed due to the spf. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00015 |
| MDR Report Key | 8631438 |
| Report Source | CONSUMER |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-14 |
| Date Mfgr Received | 2019-05-02 |
| Device Manufacturer Date | 2015-12-14 |
| Date Added to Maude | 2019-05-22 |
| 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 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0287-2019 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF PLUS-MINI (60 ?A/W) |
| Generic Name | SPF PLUS MINI |
| Product Code | LOE |
| Date Received | 2019-05-22 |
| Model Number | N/A |
| Catalog Number | 10-1398M |
| 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 | 2019-05-22 |