MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-05-16 for UNKNOWN CICA CARE manufactured by Smith & Nephew Medical Ltd..
[75209805]
Patient Sequence No: 1, Text Type: N, H10
[75209806]
It was reported that a cica-care caused pain, burning & swelling around a surgical scar. The product had only been in use for a few hours, but the areas took a month to heal.
Patient Sequence No: 1, Text Type: D, B5
[106446717]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2017-00135 |
| MDR Report Key | 6568466 |
| Report Source | CONSUMER |
| Date Received | 2017-05-16 |
| Date of Report | 2017-09-05 |
| Date Mfgr Received | 2017-04-24 |
| Date Added to Maude | 2017-05-16 |
| 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 | MR MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| 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 | UNKNOWN CICA CARE |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT |
| Product Code | MDA |
| Date Received | 2017-05-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-16 |