MEPLIEX BORDER 295800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,health professional report with the FDA on 2019-04-11 for MEPLIEX BORDER 295800 manufactured by Molnlycke.

Event Text Entries

[141729314] A patient reported having experienced two large blisters a few days post-op total knee arthroplasty under the adhesive border of the dressing used to cover the incision. One of the blisters broke open and is believed to be an entry point for infection. Although likely limited to cellulitis, it was treated as a deep wound infection, resulting in a secondary surgery to reopen wound, irrigate, debride and replace the polyethylene tibial component of the knee prosthesis, followed by an ongoing six months of iv and oral antibiotic therapy. Follow up information received from the patient reported previous history of blistering when using steri-strips and unspecified reactions to adhesive. The wound has since healed. The patient stated the infectious disease doctor presumed the entry site of the infection was due to a serous blister. Follow up information received from the surgeon indicates the patient was advised to follow up with the doctor after the first surgery, but did not. She began physical therapy as prescribed and reported redness around the periwound and formation of a blister to the physical therapist, who advised the patient to go to emergency room due to potential infection. A review of the patient's medical records indicates initial surgery was performed with no apparent intra-operative complications and a mepilex dressing was placed. The patient presented at the er 1 week status post op a left tka with erythema and warmth to her knee that has been getting worse over previous 3 days. No wound drainage, no fever or chills. Certain superficial cellulitis, with possible deep infection. Revision surgery performed by same surgeon with no apparent intra-operative complications. Ancef 2 grams q8hrs per infectious disease, follow culture results. Pico skin vac placed x 1 week, then replace with regular mepilex dressing.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004763499-2019-00003
MDR Report Key8506902
Report SourceCONSUMER,HEALTH PROFESSIONAL
Date Received2019-04-11
Date of Report2019-03-12
Date of Event2018-10-03
Date Mfgr Received2019-03-12
Date Added to Maude2019-04-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS PAT STRAHL
Manufacturer Street5550 PEACHTREE PARKWAY SUITE 500
Manufacturer CityNORCROSS GA 30092
Manufacturer CountryUS
Manufacturer Postal30092
Manufacturer Phone4042700985
Manufacturer G1MOLNLYCKE
Manufacturer Street5550 PEACHTREE PARKWAY SUITE 500
Manufacturer CityNORCROSS GA 30092
Manufacturer CountryUS
Manufacturer Postal Code30092
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMEPLIEX BORDER
Generic NameBORDERED FOAM DRESSING
Product CodeNAC
Date Received2019-04-11
Model Number295800
OperatorLAY USER/PATIENT
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMOLNLYCKE
Manufacturer Address5550 PEACHTREE PARKWAY SUITE 500 NORCROSS GA 30092 US 30092


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-11

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