MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BRD SACRUM CT10; BANDAGE, LIQUID

Model Number	66801031
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported patient has developed bed sores after using allevyn.
Additional Manufacturer Narrative
Please review attached for investigation results.(b)(4).

• Brand Name: ALLEVYN GENTLE BRD SACRUM CT10
• Common Device Name: BANDAGE, LIQUID
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU32B N; UK HU32BN
• MDR Report Key: 6979786
• Report Number: 8043484-2017-00259
• Device Sequence Number: 16343414
• Product Code: KMF
• UDI-Device Identifier: 05000223477813
• UDI-Public: (01)05000223477813(17)200228(10)201709
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K945330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2018

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
• Operator of Device: Lay User/Patient
• Device Model Number: 66801031
• Device Catalogue Number: 66801031
• Device Lot Number: 201709
• Initial Date Received by Manufacturer: 10/13/2017
• Supplement Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR