MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-03 for CICA CARE 66250707 manufactured by Smith & Nephew Medical (suzhou) Limited.
[6018732]
It was reported that after using the product for one month, the skin under the cica care gel sheet become darker and a little dry when compared with the surrounding skin.
Patient Sequence No: 1, Text Type: D, B5
[14252256]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2015-00165 |
| MDR Report Key | 4889804 |
| Report Source | 07 |
| Date Received | 2015-07-03 |
| Date of Report | 2014-11-20 |
| Date of Event | 2014-11-20 |
| Date Mfgr Received | 2014-11-20 |
| Date Added to Maude | 2015-07-06 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR TERRY MCMAHON |
| Manufacturer Street | 970 LAKE CARILLON DR, |
| Manufacturer City | ST PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal | 33716 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL (SUZHOU) LIMITED |
| Manufacturer Street | CFZ A, NO 200, MIDDLE SUHONG R SUZHOU INDUSTRIAL PARK, |
| Manufacturer City | SUZHOU, P.R C215021 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | C215021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CICA CARE |
| Generic Name | CICA CARE 12X15CM CTN 10 |
| Product Code | MDA |
| Date Received | 2015-07-03 |
| Catalog Number | 66250707 |
| Lot Number | 1317 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL (SUZHOU) LIMITED |
| Manufacturer Address | CFZ A, NO 200, MIDDLE SUHONG R SUZHOU INDUSTRIAL PARK, SUZHOU, P.R C215021 CH C215021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-03 |