MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. MELOLIN P/PACK 5X5CM BE CTN 25; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66030260

Device Problem Moisture or Humidity Problem (2986)

Patient Problem Tissue Damage (2104)

Event Date 11/06/2019

Event Type  Injury  

Event Description

It was reported that there was maceration caused by moisture while using melolin.It is unknown if medical intervention was needed.

Manufacturer Narrative

The device, intended for use in treatment, or a control sample, has not been returned for evaluation.Without this we are unable to complete an analysis to establish a relationship between the failure reported.Medical/clinical investigation reported that without product lot, return for evaluation and/or clinically relevant supporting documentation, a thorough medical investigation could not be performed.Patient impact beyond the reported maceration could not be assessed.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A risk management review has taken place in relation to this complaint, the risk file contains multiple causes of decreased absorption or reduced fluid uptake which among other harms can lead to wound maceration.Without further details a full failure mode cannot be identified.A review of the instructions for use found adequate warnings, precautions relating to the product range.Indications - melolin may be used on its own to dress dry sutured wounds, superficial cuts and abrasions, and other lightly exuding lesions.It may also be used as the primary wound contact layer for more heavily exuding wounds, if backed by a second absorbent dressing.Contra-indications - in common with other perforated plastic film dressings, melolin should be used with caution in the treatment of leg ulcers that produce copious quantities of very viscous exudate.Under these circumstances, the exudate may become trapped under the dressing, leading to maceration and inflammation of the surrounding skin.A review of the device history has also not been possible, however all products released are done so according to design specification, there is no indication that the product failed to meet this.Complaint history for the reported failure has been reviewed and revealed this complaint as the only instance in the previous four years.We have been unable to determine a root cause on this occasion.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.

• Brand Name: MELOLIN P/PACK 5X5CM BE CTN 25
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 9409522
• MDR Text Key: 169022483
• Report Number: 8043484-2019-00880
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: K821246
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66030260
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other