MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-13 for EXOFIN SKIN GLUE manufactured by Unk.
[166608615]
Severe allergic skin reaction suspected due to exofin glue. Pt one week post breast reduction surgery. Used for skin closure in the operating room. We have been seeing a number of these lately and gave stopped using the product. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5091087 |
| MDR Report Key | 9322325 |
| Date Received | 2019-11-13 |
| Date of Report | 2019-11-12 |
| Date of Event | 2019-11-12 |
| Date Added to Maude | 2019-11-14 |
| 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 |
| 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 SKIN GLUE |
| Generic Name | CUTANEOUS TISSUE ADHESIVE WITH MESH |
| Product Code | OMD |
| Date Received | 2019-11-13 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-13 |