MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-07-19 for CICA-CARE 15CM X 12CM CTN 1 66250706 manufactured by Smith & Nephew Medical Ltd..
[80398112]
Patient Sequence No: 1, Text Type: N, H10
[80398113]
It was reported patient had skin peeling when removed the dressing from the skin. When cica care was removed, the skin was pulled and has peeled off, it was confirmed the exudate fluid from the skin peeling area.
Patient Sequence No: 1, Text Type: D, B5
[106649933]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2017-00175 |
| MDR Report Key | 6724246 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-07-19 |
| Date of Report | 2017-10-13 |
| Date of Event | 2017-06-23 |
| Date Mfgr Received | 2017-06-26 |
| Date Added to Maude | 2017-07-19 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | NO.12 WUXIANG ROAD. COMPREHENSIVE FREE ZONE WEST Z |
| Manufacturer City | SUZHOU 215021 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215021 |
| 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 | 2017-07-19 |
| Model Number | 66250706 |
| Catalog Number | 66250706 |
| Lot Number | 201635 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| 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 HU32BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-19 |