MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE HEEL (GLOBAL) PACK OF 5; DRESSING,WOUND,OCCLUSIVE

Model Number 66021304

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2020

Event Type  malfunction  

Event Description

It was reported that after a few hours since the application of the dressings, it didn¿t adhere to the heels.It seems that the dressing didn¿t stay in a place like it should stay and seems loose.The product didn¿t match its properties.There were no delays and the treatment was completed with a backup device.There was no patient harm reported.Results of the investigation have concluded that this device presented silicone remained on the carrier, which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

• Brand Name: ALLEVYN LIFE HEEL (GLOBAL) PACK OF 5
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX ; 5123913905
• MDR Report Key: 11273886
• MDR Text Key: 230109694
• Report Number: 8043484-2021-00260
• Device Sequence Number: 1
• Product Code: NAD
• UDI-Device Identifier: 05000223482503
• UDI-Public: 05000223482503
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 66021304
• Device Catalogue Number: 66801304
• Device Lot Number: 201920
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Date Manufacturer Received: 01/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1