MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2016-09-06 for CICA-CARE 15CM X 12CM CTN 1 66250706 manufactured by Smith & Nephew Medical Ltd..
[53906148]
(b)(6)
Patient Sequence No: 1, Text Type: N, H10
[53906149]
It was reported that after caesarean section, a patient used cicacare. After 3 or 4 days, she got hives on her feet, which spread to her neck. These were healed with an unknown allergy medicine.
Patient Sequence No: 1, Text Type: D, B5
[60881447]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2016-00115 |
| MDR Report Key | 5928250 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2016-09-06 |
| Date of Report | 2016-08-15 |
| Date of Event | 2016-08-12 |
| Date Mfgr Received | 2016-08-29 |
| Date Added to Maude | 2016-09-06 |
| 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 | 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 (SUZHOU) LIMITED |
| Manufacturer Street | NO.12 WUXIANG ROAD. COMPREHENSIVE FREE ZONE |
| 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 | 2016-09-06 |
| Model Number | 66250706 |
| Catalog Number | 66250706 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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. Required No Informationntervention | 2016-09-06 |