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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE SACRUM (LARGE) PACK OF 10 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN LIFE SACRUM (LARGE) PACK OF 10 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66801307
Device Problem Mechanical Problem (1384)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/03/2018
Event Type  malfunction  
Event Description
It was reported that the dressing ripped when they went to peel it back and assess the patient.
 
Manufacturer Narrative
We have now concluded our investigation for the complaint received. The batch records were reviewed and it could be confirmed that the products had progressed through a satisfactory release process which involved testing the product against the requirements of its finished product specification. There was no issue identified during the manufacturing process that could have caused or contributed to the complaint problem. A review of the complaint history for this defect shows a very low level of complaints for this issue based on volumes manufactured. The retained sample was assessed and found to perform as expected. The investigation did not find product defect or manufacturing process issue. The complaint sample and product lot were not available at this time. Once the sample received, an assessment will take place to make further investigation. Based on the available information, the cause of the complaint is inconclusive so no action can be taken at present. Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products. We will continue to monitor for any adverse trends relating to this product range.
 
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Brand NameALLEVYN LIFE SACRUM (LARGE) PACK OF 10
Type of DeviceDRESSING,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
sarah freestone
101 hessle road
hull, HU3 2-BN
UK   HU3 2BN
MDR Report Key8040450
MDR Text Key126517297
Report Number8043484-2018-00352
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2021
Device Catalogue Number66801307
Device Lot Number201818
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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