MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-12 for CICA-CARE 15CM X 12CM CTN 1 66250706 manufactured by Smith & Nephew Medical Ltd..
[138541306]
It was reported that during use of the product, the patient suffered from an infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2019-00174 |
| MDR Report Key | 8412695 |
| Date Received | 2019-03-12 |
| Date of Report | 2019-04-16 |
| Date of Event | 2012-12-02 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-03-12 |
| 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 G1 | SMITH & NEPHEW MEDICAL LTD. |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CICA-CARE 15CM X 12CM CTN 1 |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT |
| Product Code | MDA |
| Date Received | 2019-03-12 |
| Catalog Number | 66250706 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-12 |