MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-06-13 for OSTEOGEN 10-1320M manufactured by Ebi, Llc.
[2018082]
It was reported that patient complained of pain and swelling of leg. A revision surgery was conducted at which radio-opaque material was found around the battery of the implanted device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2242816-2011-00065 |
| MDR Report Key | 2122175 |
| Report Source | 07 |
| Date Received | 2011-06-13 |
| Date of Report | 2011-05-16 |
| Date of Event | 2011-05-11 |
| Date Mfgr Received | 2011-05-16 |
| Device Manufacturer Date | 2010-02-17 |
| Date Added to Maude | 2011-06-14 |
| 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 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEOGEN |
| Generic Name | IMPLANTABLE BONE STIMULATOR |
| Product Code | LOE |
| Date Received | 2011-06-13 |
| Returned To Mfg | 2011-05-16 |
| Catalog Number | 10-1320M |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC |
| Manufacturer Address | 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-13 |