MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2014-10-07 for ACCELL EVO3, 2.5CC 02-5000-025 manufactured by Isotis Orthobiologics, Inc.
[18364811]
It was reported; the cover on the plastic container inside the box was not secure as seen by the lack of adhesive. Box had not been previously opened. This occurred on (b)(6) 2014 product was not implanted or used on a patient.
Patient Sequence No: 1, Text Type: D, B5
[18533025]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090010-2014-00026 |
| MDR Report Key | 4156522 |
| Report Source | 07,08 |
| Date Received | 2014-10-07 |
| Date of Report | 2014-09-15 |
| Date of Event | 2014-09-12 |
| Date Mfgr Received | 2014-09-15 |
| Date Added to Maude | 2014-10-20 |
| 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 | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCELL EVO3, 2.5CC |
| Generic Name | ACCELL |
| Product Code | MBP |
| Date Received | 2014-10-07 |
| Returned To Mfg | 2014-09-18 |
| Catalog Number | 02-5000-025 |
| Lot Number | 140973 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-07 |