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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 Ejection Problem (4009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2020
Event Type  malfunction  
Event Description
It was reported that customer first let representative knows of the issue when s & n was aware that there was a silicone issue with the allevyn dressings. After finding the issue and changed the manufacturing process, representative let the customer know she shouldn't be seeing this problem any longer. As of today, (b)(6) 2020, my customer said she has been meaning to send me pictures of the silicone issue still occurring. Photos attached and no harm or injury to the patient reported.
 
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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 east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer Contact
sarah freestone
101 hessle road
hull HU3 2-BN
UK   HU3 2BN
4407940038
MDR Report Key10176395
MDR Text Key195811815
Report Number8043484-2020-00886
Device Sequence Number1
Product Code NAD
UDI-Device Identifier04582111154972
UDI-Public4582111154972
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
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
Report Date 04/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66801307
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2021
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

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