MAUDE Adverse Event Report: ADVANCED MEDICAL SOLUTIONS ACTIVHEAL FOAM NON-ADHESIVE; TRILAMINATE FOAM-NON-ADHESIVE

Model Number 5CM X 5CM

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

A complaint was reported stating that a carton of activheal non adhesive trilaminate foam was received containing 2 dressings with ''a few black marks''.The dressings were discarded prior to use and were not used on a patient.As two dressings have been identified to contain this contaminant out of 3000 dressings, this gives a remote occurrence rate of (b)(4) (o1).There have not been other complaints received regarding black marks for this product and therefore this is deemed to be an isolated incident.No photographs have been provided and based on the limited visual description provided we cannot be certain on the size or detectability of this defect.In the event that this is to reoccur, if the marking is detectable it is considered that a clinician would reject the dressing as per good clinical practice.However, if this defect is undetectable and the dressing is used on a patient, there is risk for a serious deterioration of health resulting from patient infection,any further occurrences of this defect are required to be reported to ams.As such it is determined that the defect could resent itself and be undetected by a clinician in such scenario this deefect could cause or contribute to a death or serious injury.

Event Description

A complaint was reported stating that a carton of activheal non adhesive trilaminate foam was received containing 2 dressings with ''a few black marks''.The dressings were discarded prior to use and were not used on a patient.As two dressings have been identified to contain this contaminant out of 3000 dressings, this gives a remote occurrence rate of (b)(4) (o1).There have not been other complaints received regarding black marks for this product and therefore this is deemed to be an isolated incident.Photographs included, show the dressing to have several small black marks near the corner of the dressing.In the event that this is to reoccur, if the marking is detectable it is considered that a clinician would reject the dressing as per good clinical practice.However, if this defect is undetectable and the dressing is used on a patient, there is risk for a serious deterioration of health resulting from patient infection, at this time there is no requirement for a fsca.Any further occurrences of this defect are required to be reported to ams.

• Brand Name: ACTIVHEAL FOAM NON-ADHESIVE
• Type of Device: TRILAMINATE FOAM-NON-ADHESIVE
• Manufacturer (Section D): ADVANCED MEDICAL SOLUTIONS; premier park, 33 road one; winsford industrial estate; winsford, cheshire CW7 3 RT; UK CW7 3RT
• Manufacturer (Section G): ADVANCED MEDICAL SOLUTIONS; winsford industrial estate; 33 road one, premier park; winsford, CW7 3 RT; UK CW7 3RT
• Manufacturer Contact: adam gregory ; premier park, 33 road one; winsford industrial estate; winsford, cheshire CW7 3-RT ; UK CW7 3RT
• MDR Report Key: 12614658
• MDR Text Key: 276594128
• Report Number: 8044178-2021-00005
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5CM X 5CM
• Device Catalogue Number: 10015066
• Device Lot Number: W00052455
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other