MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2013-10-07 for DBP PUTTY 5CC manufactured by Isotis Orthobiologics, Inc.
[18571084]
The customer reported the dynablast putty 5cc was moldy. It was not used on a pt.
Patient Sequence No: 1, Text Type: D, B5
[18767909]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090010-2013-00010 |
| MDR Report Key | 3464156 |
| Report Source | 05,08 |
| Date Received | 2013-10-07 |
| Date of Report | 2013-10-07 |
| Date Mfgr Received | 2013-09-10 |
| Date Added to Maude | 2014-01-09 |
| 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 DRIVE |
| 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 | DBP PUTTY 5CC |
| Generic Name | NA |
| Product Code | NUN |
| Date Received | 2013-10-07 |
| Lot Number | 120796 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ISOTIS ORTHOBIOLOGICS, INC |
| Manufacturer Address | IRVINE CA 96218 US 96218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-07 |