FDA Adverse Event
Malfunction
Summary report: N
COSEAL
MDR report key: 6116689
·
Received November 21, 2016
Report
- Report Number
- 1416980-2016-17497
- Event Type
- Malfunction
- Date Received
- November 21, 2016
- Report Date
- December 13, 2016
- Manufacturer
- BAXTER HEALTHCARE - HAYWARD
- Product Code
- NBE
- PMA / PMN Number
- P030039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT COSEAL HAD PARTICULATE MATTER. THE EVENT WAS FURTHER DESCRIBED AS THE POLYETHYLENE GLYCOL (PEG) SOLUTION WOULD NOT FLOW OUT OF THE SYRINGE DUE TO WHAT APPEARED TO BE VISIBLE PARTICLES IN THE PEG SYRINGES. THIS OCCURRED PRIOR TO PATIENT USE, SO THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767512 | COSEAL | SEALANT,POLYMERIZING | NBE | BAXTER HEALTHCARE - HAYWARD | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |