MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-18 for REMOVE WIPES BOX OF 50 01 403100 manufactured by Smith & Nephew Medical Ltd..
[124265113]
Patient Sequence No: 1, Text Type: N, H10
[124265114]
It was reported that patient suffered from burns during use of the product.
Patient Sequence No: 1, Text Type: D, B5
[134244035]
We have now concluded our investigation into this product complaint for a remove wipes which caused burning. Visual inspection of the product could not be completed since the product tube was not returned. Also without a lot number, a review of the packaging batch record could not be completed. All batches are tested for compliance with product specifications prior to release. Complaints of a similar nature will be closely monitored for any adverse trends and further action considered. Smith and nephew are continually investigating ways to develop and improve our products and we will continue to monitor for any adverse trends relating to this product range.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2018-00337 |
| MDR Report Key | 7982340 |
| Date Received | 2018-10-18 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-09-20 |
| Date Mfgr Received | 2018-09-20 |
| Date Added to Maude | 2018-10-18 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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 28N |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 28N |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | REMOVE WIPES BOX OF 50 01 |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2018-10-18 |
| Catalog Number | 403100 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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 28N UK HU3 28N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2018-10-18 |