MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD ALLEVYN ADH 12.5X12.5XM CTN 10; DRESSING,WOUND,OCCLUSIVE

Model Number 66800760

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Reaction (2414)

Event Date 07/28/2014

Event Type  Injury  

Event Description

The product was used for pressure ulcer prevention, but allergies occurred in many cases.

• Brand Name: ALLEVYN ADH 12.5X12.5XM CTN 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD; 101 hessle road; hull HU3 2BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL SUZHOU LTD; cfz a, no. 200 mid suhong rd; suzhou industrial park; suzhou, p.r. C215 021; CH C215021
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; st petersburg, FL 33716
• MDR Report Key: 4891583
• MDR Text Key: 6536211
• Report Number: 8043484-2015-00221
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 66800760
• Device Catalogue Number: 66800760
• Device Lot Number: 50437184
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2014
• Initial Date FDA Received: 07/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention