SECURA MOIST CLEANSE 59430900

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-15 for SECURA MOIST CLEANSE 59430900 manufactured by Smith & Nephew Medical.

Event Text Entries

[57551530] (b)(6).
Patient Sequence No: 1, Text Type: N, H10

[57551531] It was reported patient suffered burns when product was applied.
Patient Sequence No: 1, Text Type: D, B5

[68542378]
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 3006760724-2016-00154
• MDR Report Key: 6032334
• Date Received: 2016-10-15
• Date of Report: 2016-10-07
• Date Mfgr Received: 2016-10-11
• Date Added to Maude: 2016-10-15
• 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
• 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: 3

Device Details

• Brand Name: SECURA MOIST CLEANSE
• Generic Name: DEGREASER, SKIN, SURGICAL
• Product Code: KOY
• Date Received: 2016-10-15
• Model Number: 59430900
• Catalog Number: 59430900
• Lot Number: 48891
• 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
• Manufacturer Address: 101 HESSLE ROAD HULL HU32BN UK HU32BN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2016-10-15