MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2020-02-26 for NATURA 401512 manufactured by Convatec Dominican Republic Inc.
[183097151]
Based on the available information, this event is deemed to be a serious injury. This complaint has been evaluated. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[183097152]
It was reported that about 12 months ago, the end user developed a red, itchy rash under the outer edge of the tape collar and on her abdomen where the pouch comfort panel is in contact with her skin. The symptoms started as a moist red rash, then became runny with a strong odor. It eventually dried up and skin became flaky. The cycle then started again. She saw her primary care doctor several months ago, who diagnosed her with a fungal rash and prescribed oral diflucan, and topical nystatin cream. She took several rounds of the diflucan and had been using the nystatin for months with no change in symptoms. She then recently saw a nurse who recommended nystatin powder instead. So, she has been applying the powder topically for the past several weeks. Her skin care routine is to clean with either dial soap, perineal cleanser or plain water, then apply 3 layers of nystatin with a barrier wipe over each layer. She reported that her symptoms have not responded with this treatment either. She then recently tried using dry gauze under the outer edges of the tape collar and under her pouch to keep the pouch material off her skin. She thought her symptoms improved slightly when she used the gauze. No photo is available at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9618003-2020-03470 |
| MDR Report Key | 9756038 |
| Report Source | CONSUMER,HEALTH PROFESSIONAL |
| Date Received | 2020-02-26 |
| Date of Event | 2019-02-06 |
| Date Mfgr Received | 2020-02-06 |
| Date Added to Maude | 2020-02-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Street | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA |
| Manufacturer City | SAN CRISTOBAL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NATURA |
| Generic Name | POUCH, COLOSTOMY |
| Product Code | EZQ |
| Date Received | 2020-02-26 |
| Model Number | 401512 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC DOMINICAN REPUBLIC INC |
| Manufacturer Address | KM 18.5 PARQUE INDUSTRIAL ITABO, S.A. HAINA SAN CRISTOBAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |