MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for DIRECTGEN? PUTTY PLUS DPP250 manufactured by Implant Direct Sybron Manufacturing Llc.
[112573768]
Per the complaint, the patient was in ofc for wall defect. The doctor opened dpp250 and upon completing treatment, realized that the sticker indicated that the product was expired. It expired 02/02/2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3001617766-2018-00157 |
| MDR Report Key | 7628220 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-05-25 |
| Date Added to Maude | 2018-06-22 |
| 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 | MRS. ADRIENNE STOTT |
| Manufacturer Street | 3050 EAST HILLCREST DRIVE |
| Manufacturer City | THOUSAND OAKS CA 91362 |
| Manufacturer Country | US |
| Manufacturer Postal | 91362 |
| Manufacturer Phone | 8184443300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DIRECTGEN? PUTTY PLUS |
| Generic Name | CORTICAL BONE VOLUME DENTAL PUTTY |
| Product Code | NUN |
| Date Received | 2018-06-22 |
| Catalog Number | DPP250 |
| Lot Number | THB60368292 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Manufacturer Address | 3050 EAST HILLCREST DRIVE THOUSAND OAKS CA 91362 US 91362 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-22 |