MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-10-03 for CICA CARE 6X12CM CTN 1 66250704 manufactured by Smith & Nephew Medical Ltd..
[56185063]
Patient Sequence No: 1, Text Type: N, H10
[56185064]
It was reported that a patient's 6" scar re-opened after uing cica-care. The scar had been healed for approximately 1. 5 months. Treatment was discontinued.
Patient Sequence No: 1, Text Type: D, B5
[60319489]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2016-00133 |
| MDR Report Key | 5993438 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-10-03 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-09-01 |
| Date Mfgr Received | 2016-09-28 |
| Date Added to Maude | 2016-10-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS CLAUDIA ODOY |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer Phone | 0628320660 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CICA CARE 6X12CM CTN 1 |
| Generic Name | CICA CARE 6X12CM CTN 1 |
| Product Code | MDA |
| Date Received | 2016-10-03 |
| Model Number | 66250704 |
| Catalog Number | 66250704 |
| Lot Number | 1327 |
| ID Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-03 |