MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-30 for RECEDO TOPICAL GEL manufactured by Exeltis.
[71617520]
The product is supposed to dry in 3 minutes but it does not. Stays sticky after 8 hours of using it. The manufacturer requested the product be sent back and it has not given me a replacement and they have not informed me if or when it will be sent to me. No explanations received from them on this product. They have not offered a reimbursement either. Is the product compounded: yes. Quantity: other. Frequency: twice a day. How was it taken or used: topical. Date the person first started taking or using the product: (b)(6) 2017. Date the person stopped taking or using the product: (b)(6) 2017. Why was the person using the product: to try to minimize scar tissue on face.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068801 |
| MDR Report Key | 6450666 |
| Date Received | 2017-03-30 |
| Date of Report | 2017-03-29 |
| Date of Event | 2017-03-10 |
| Date Added to Maude | 2017-03-31 |
| 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 | PATIENT |
| 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 | RECEDO TOPICAL GEL |
| Generic Name | RECEDO TOPICAL GEL |
| Product Code | MDA |
| Date Received | 2017-03-30 |
| Lot Number | 160008 |
| Device Expiration Date | 2018-01-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXELTIS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-30 |