MAUDE Adverse Event Report: MOLNYCKE HEALTH CARE MEPILEX BORDER POST OP AG; WOUND DRESSING

Model Number	498650
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Skin Irritation (2076); Swelling (2091); Post Operative Wound Infection (2446)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The warnings and precautions section of the instructions for use (ifu) states mepilex ag is intended for short-term use up to 4 weeks.For long-term use, a clinical assessment by a physician is recommended.A similar size product available in the us was selected for fda submission.
Event or Problem Description
A nurse reported a patient may have developed a sensitivity to mepilex ag dressing.Bilateral amputee continually using mepilex ag since (b)(6).Wound developed staph, redness (erythema) and swelling.Use of mepilex ag has been discontinued and iv antibiotics administered.The nurse stated there is no issue with the product, but it has been in use for too long.Request was made for additional information.Additional information received (b)(6) 2018 indicated mepilex ag dressings were in use on arms and legs on superficial skin breakdowns post amputation of 4 limbs below elbow and below knee.Patient was readmitted (b)(6) 2018 for sepsis unknown site.Wounds were cleansed with normal saline, with 2x week dressing changes.Reaction reported of redness (erythema), skin irritation, blisters and infection, 30cmx20cm size, under the area where the dressing was placed.Use of mepilex ag dressing was discontinued.Antiseptic wash, betadine gauze to all areas, then daily sorbact dressing.Wound is healing well with iv antibiotics.Surgeon has requested use of mepilex ag dressing to resume.

• Brand Name: MEPILEX BORDER POST OP AG
• Common Device Name: WOUND DRESSING
• Manufacturer (Section D): MOLNYCKE HEALTH CARE; 5550 peachtree parkway; suite 500; norcross GA 30092
• MDR Report Key: 7987522
• Report Number: 3004763499-2018-00005
• Device Sequence Number: 18128923
• Product Code: FRO
• Combination Product (Y/N): N
• PMA/510(K) Number: K100029
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/21/2018

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: Health Professional
• Device Model Number: 498650
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR