Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIGRID 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW MEDICAL LTD. OPSITE FLEXIGRID 6X7CM CTN 100; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Catalog Number 4628
Device Problem Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2022
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference: (b)(4).
 
Event Description
It was reported that, when the package of an opsite flexigrid 6x7cm ctn 100 was opened, several black stains were found on the dressing.As this was noticed upon set-up or inspection, the patient was not involved at that moment.
 
Manufacturer Narrative
It was reported that, when the package of an opsite flexigrid 6x7cm ctn 100 was opened, several black stains were found on the dressing.As this was noticed upon set-up or inspection, the patient was not involved at that moment.The device intended for use in treatment was not returned for analysis.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.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 the finished product specification.There was also no issue identified during the manufacturing process that could have caused or contributed to the complaint problem.A complaint history review revealed no similar instances in the last three years.A risk management review concluded that without further information the alleged failure mode can not be directly linked to a specific failure mode within the risk file although there are several failure modes which can result in dressing contamination.Probable root cause is that the contamination has been on the raw material used to make the dressing, which has not been identified on a quality check or that the dressing has not been stored in accordance with the ifu which has caused discoloration.The devices must be stored in the conditions outlined in the ifu to prevent environmental factors such as temperature from affecting them.An increase in temperature above that recommended may affect the device, which can cause issues such as those described in the event.The users of the reported product are advised to consult the ifu, to prevent future occurrences of the reported issue.This guide provides comprehensive instructions of the operation, use and limitations of the device, including the correct conditions in which the device must be stored.This investigation is now complete, with no corrective actions required.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
OPSITE FLEXIGRID 6X7CM CTN 100
Type of Device
TAPE AND BANDAGE, ADHESIVE
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
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key14210210
MDR Text Key290164202
Report Number8043484-2022-00126
Device Sequence Number1
Product Code KGX
UDI-Device Identifier05000223046286
UDI-Public5000223046286
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4628
Device Lot Number2028
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/31/2022
Initial Date FDA Received04/26/2022
Supplement Dates Manufacturer Received06/01/2022
Supplement Dates FDA Received06/02/2022
Date Device Manufactured07/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age33 YR
Patient SexFemale
-
-