MAUDE Adverse Event Report: ADVANCED MEDICAL SOLUTIONS LTD. PRIMASEAL AG+; SURGICAL SILVER POST OPERATIVE DRESSING,,

Model Number MSCPS36

Device Problem No Apparent Adverse Event (3189)

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

Event Type  malfunction  

Event Description

The distributor initially reported a post-operative infection with the use of primaseal post-op dressing, with poor adherence of the dressing.The distributor then clarified there was no infection, only a concern about possible infection due to lack of adhesion of the dressing.There are 4 dressings associated with the complaint.It is undetermined whether the 4 dressings related to 4 different patients or 1 patient.Therefore as a precautionary measure this event is being reported 4 times.

Manufacturer Narrative

In fda's medical device reporting for manufacturers' document issued on november 8, 2016, a "serious injury" is an injury or illness that is life threatening, results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent damage to a body structure.' if this malfunction was to recur, in the worst case, it could lead to an infection that could require medical intervention.This malfunction will be reported as the chance of a death or serious injury occurring as a result of a recurrence of the malfunction is not remote.However, there was no serious injury associated with this event.

• Brand Name: PRIMASEAL AG+
• Type of Device: SURGICAL SILVER POST OPERATIVE DRESSING,,
• Manufacturer (Section D): ADVANCED MEDICAL SOLUTIONS LTD.; premier park, 33 road one; winsford industrial estate; winsford, CW7 3 RT,; UK CW7 3RT,
• Manufacturer (Section G): ADVANCED MEDICAL SOLUTIONS LTD.; premier park, 33 road one; winsford industrial estate; winsford, CW7 3 RT,; UK CW7 3RT,
• Manufacturer Contact: rebecca worthington ; premier park, 33 road one; winsford industrial estate; winsford, CW7 3-RT,, ; UK CW7 3RT,,
• MDR Report Key: 14187596
• MDR Text Key: 289897625
• Report Number: 8044178-2022-00003
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): Y
• PMA/PMN Number: K180634
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MSCPS36
• Device Lot Number: W00049131
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other