MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-10 for CICA CARE 6X12CM CTN 5 66320703 manufactured by Smith & Nephew Medical Ltd..
[129874920]
Patient Sequence No: 1, Text Type: N, H10
[129874921]
It was reported that during use of cica-care, the patient suffered from second degree burns at the place where the product was applied.
Patient Sequence No: 1, Text Type: D, B5
[134384426]
The associated complaint sample was not returned for evaluation, please see below the results of our investigation: we have now concluded our investigation into this complaint. A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant. In addition it can be confirmed that all finished product specification testing was satisfied at the point of release. No complaint sample was available for assessment. No clinically relevant documentation was provided, therefore, a thorough medical investigation could not be performed. No further medical assessment is warranted at this time. The investigation did not find product defect or manufacturing process issue so no action is required at present. Once a sample is received, we will assess and make further investigation. Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products. We will continue to monitor for any adverse trends relating to this product range.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2018-00432 |
| MDR Report Key | 8148534 |
| Date Received | 2018-12-10 |
| Date of Report | 2019-01-29 |
| Date of Event | 2018-11-11 |
| Date Mfgr Received | 2018-11-20 |
| Date Added to Maude | 2018-12-10 |
| 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 | DR. SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU3 2BN |
| 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 | 0 |
| Brand Name | CICA CARE 6X12CM CTN 5 |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT |
| Product Code | MDA |
| Date Received | 2018-12-10 |
| Catalog Number | 66320703 |
| Lot Number | 201731 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2018-12-10 |