MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-02 for CICA CARE 6X12CM CTN 3 66000702 manufactured by Smith & Nephew Medical Ltd..
[6018649]
Used gel sheets on legs and left with 3 x square red scars where gel sheets were placed on legs.
Patient Sequence No: 1, Text Type: D, B5
[13521889]
(b)(4)
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2015-00106 |
| MDR Report Key | 4886739 |
| Report Source | 07 |
| Date Received | 2015-07-02 |
| Date of Report | 2014-01-02 |
| Date of Event | 2013-11-30 |
| Date Mfgr Received | 2014-01-02 |
| Date Added to Maude | 2015-07-02 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS CLAUDIA ODOY |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU32BN |
| 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 3 |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT |
| Product Code | MDA |
| Date Received | 2015-07-02 |
| Returned To Mfg | 2014-01-16 |
| Model Number | 66000702 |
| Catalog Number | 66000702 |
| Lot Number | 1324 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU32BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-02 |