MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. *ALLEVYN LIFE 21X21 SPAIN CTN 3; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66801743

Device Problem Suction Problem (2170)

Patient Problem Injury (2348)

Event Date 02/27/2018

Event Type  Injury  

Event Description

It was reported that a dressing 21x21, placed on the heel, was not absorbing the exudate which led to the maceration of the skin.

Manufacturer Narrative

The product was not evaluated due to no sample was returned for investigation.Investigation results: our investigation into this complaint has now concluded.As of today, no additional information requested or sample for this complaint has become available.Without further information we cannot progress our investigation or confirm the details supplied in this complaint.In the absence of additional information, our investigation remains inconclusive.At this time an exact root cause cannot be determined.If additional information becomes available in the future, this case will be reopened.An investigation into the manufacturing paperwork associated with this product code and lot has been carried out.This review detailed that manufacture of the product had occurred in accordance with defined procedures and specifications.No record of any problems occurring during manufacture of the product have been made which may be related to this complaint.Due to the nature of the reported issue this has been passed to one of our medical specialists who has made the following comments it was reported that this complaint relates to 33 dressings from the same lot.No specific patient supporting clinical documentation has been provided which could identify any comorbid conditions, current medications and/or past surgical history.It cannot be confirmed that the reported maceration was due to an absorbency issue with the dressing.There is no report of patient impact or current condition.No further medical assessment is able to be performed at this time.

• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer Contact: markus poettker ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 7355957
• MDR Text Key: 102991066
• Report Number: 8043484-2018-00062
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2020
• Device Catalogue Number: 66801743
• Device Lot Number: 201718
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Other