MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-02-13 for SPF-PLUS 60/M (MINI) N/A 10-1398M manufactured by Ebi, Llc.
[2533881]
It was reported that a revision surgery was conducted to remove the implantable stimulator as the patient had contracted an infection.
Patient Sequence No: 1, Text Type: D, B5
[9552509]
The physician's manual/instructions for use indicate that in randomized and non-randomized clinical studies involving 493 patients using the model spf-4, twenty-two adverse events (4%) were reported; of which 5 were for reported infection.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2012-00011 |
| MDR Report Key | 2448346 |
| Report Source | 07 |
| Date Received | 2012-02-13 |
| Date of Report | 2012-01-15 |
| Date of Event | 2012-01-14 |
| Date Mfgr Received | 2012-01-15 |
| Device Manufacturer Date | 2011-06-09 |
| Date Added to Maude | 2012-02-14 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ART KAUFMAN |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9832999300 |
| Manufacturer Country | US |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF-PLUS 60/M (MINI) |
| Generic Name | SPF-PLUS 60/M (MINI) |
| Product Code | LOE |
| Date Received | 2012-02-13 |
| Model Number | N/A |
| Catalog Number | 10-1398M |
| Lot Number | N/A |
| ID Number | N/A |
| Device Expiration Date | 2013-01-21 |
| 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 | 100 INTEPACE PARKWAY PARSIPPANY NJ 07080 US 07080 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-02-13 |