FDA Adverse Event
Malfunction
Summary report: N
AUGMENT INJECTABLE
MDR report key: 11886004
·
Received May 26, 2021
Report
- Report Number
- 3003897776-2021-00002
- Event Type
- Malfunction
- Date Received
- May 26, 2021
- Date of Event
- April 23, 2021
- Report Date
- May 26, 2021
- Manufacturer
- BIOMIMETIC THERAPEUTICS, LLC
- Product Code
- NOX
- UDI-DI
- 10859477002140
- PMA / PMN Number
- P100006
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PACKAGE HAD A 1.5CC VIAL INSTEAD OF THE 3CC VIAL. THE PRODUCT WAS DIFFICULT TO MIX BECAUSE OF THE RATION OF LIQUID TO BBTCP. THE SURGEON WAS ABLE TO INJECT AT THE SITE WITH NO PATIENT COMPLICATIONS REPORTED. THERE WAS NO BACKUP KIT AVAILABLE. NO IMPACT TO PATIENT, JUST LESS PRODUCT USED THAN PLANNED. NO DELAY
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782134 | AUGMENT INJECTABLE | FILLER, BONE VOID, SYNTHETIC PEPTIDE | NOX | BIOMIMETIC THERAPEUTICS, LLC | K30003010 | 1706343 | 10859477002140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |