MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-06 for EXOFIN EX70407 manufactured by Chemence Medical, Inc..
[72465193]
Exofin high viscosity tissue adhesive was used post cervical laminectomy. Post-op office visit patient complained of rash at incision site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068993 |
| MDR Report Key | 6475506 |
| Date Received | 2017-04-06 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-03-28 |
| Date Added to Maude | 2017-04-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | EXOFIN |
| Generic Name | 2-OCTYL CYANOACRYLATE |
| Product Code | KMF |
| Date Received | 2017-04-06 |
| Catalog Number | EX70407 |
| Lot Number | 17A2011-E4-02 |
| Device Expiration Date | 2018-06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHEMENCE MEDICAL, INC. |
| Manufacturer Address | ALPHARETTA GA 30005 US 30005 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-06 |