MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-23 for SCAR AWAY SILICONE SCAR GEL manufactured by L. Perrigo Company.
[146265177]
Instant increased nerve pain after applying scar away topical roller. Frequency: at bedtime. How was it taken or used: topical. Reason for use: scar minimization following foot tendon repair surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086899 |
| MDR Report Key | 8640751 |
| Date Received | 2019-05-23 |
| Date of Report | 2019-05-21 |
| Date of Event | 2019-05-20 |
| Date Added to Maude | 2019-05-24 |
| 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 | SCAR AWAY SILICONE SCAR GEL |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT |
| Product Code | MDA |
| Date Received | 2019-05-23 |
| Lot Number | 093 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | L. PERRIGO COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-23 |