MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-04-12 for KELO-COTE manufactured by .
[19199040]
Complainant purchased kelo-cote 15g from (b)(4) on (b)(6) 2013. Complainant used the product two days on the week of (b)(6) 2013. While using the product those two days, she noticed the areas where she rubbed the gel were feeling "rubbery", hardened, and dry. She used the product on her chest and lower stomach, bikini line area. On (b)(6) 2013, she noticed that her navel was really sore and started to open. She described as looking like a "blood shot eye. " she went to the emergency room that day and the doctor informed her that she had blisters with pus inside of them and red streaks under her navel which indicate a staph infection. The doctor prescribed her medication and her navel is back to normal now. Hospital name: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5029766 |
| MDR Report Key | 3062780 |
| Date Received | 2013-04-12 |
| Date of Report | 2013-04-04 |
| Date of Event | 2013-03-09 |
| Date Added to Maude | 2013-04-18 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KELO-COTE |
| Generic Name | ADVANCED FORMULA SCAR GEL, 15 GM |
| Product Code | MDA |
| Date Received | 2013-04-12 |
| Lot Number | 435 |
| ID Number | NDC: 40101-001 |
| Device Expiration Date | 2016-08-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-04-12 |