MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-11-14 for I-FACTOR PEPTIDE ENHANCED BONE GRAFT 700-050 manufactured by Cerapedics, Inc..
Report Number | 3007155473-2019-00014 |
MDR Report Key | 9321330 |
Report Source | DISTRIBUTOR |
Date Received | 2019-11-14 |
Date of Report | 2019-11-12 |
Date of Event | 2018-11-15 |
Date Mfgr Received | 2018-12-10 |
Device Manufacturer Date | 2018-09-28 |
Date Added to Maude | 2019-11-14 |
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 | 3 |
Event Location | 3 |
Manufacturer Contact | MR. MARK BOWERMAN |
Manufacturer Street | 11025 DOVER ST. SUITE #1600 |
Manufacturer City | WESTMINSTER CO 80021 |
Manufacturer Country | US |
Manufacturer Postal | 80021 |
Manufacturer Phone | 3039746275 |
Manufacturer G1 | CERAPEDICS, INC. |
Manufacturer Street | 11025 DOVER ST. SUITE #1600 |
Manufacturer City | WESTMINSTER CO 80021 |
Manufacturer Country | US |
Manufacturer Postal Code | 80021 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | I-FACTOR PEPTIDE ENHANCED BONE GRAFT |
Generic Name | BONE GRAFT |
Product Code | NOX |
Date Received | 2019-11-14 |
Model Number | 700-050 |
Catalog Number | 700-050 |
Lot Number | 18C0493 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | CERAPEDICS, INC. |
Manufacturer Address | 11025 DOVER ST. SUITE 1600 WESTMINSTER CO 80021 US 80021 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-14 |