MAUDE Adverse Event Report: ADVANCED MEDICAL SOLUTIONS LTD BIATAIN ALGINATE; 14-2AP ALGINATE CMC DRESSING

Model Number 3 X 44 CM

Device Problem Material Disintegration (1177)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/30/2021

Event Type  Injury  

Manufacturer Narrative

A complaint has been received stating that the coloplast biatain alginate rope dressings have disintegrated during placement and removal resulting in the patient returning to the operating room for removal of the dressing.Although this case is an isolated incident (b)(4) occurrence.This device product integrity issue has resulted in a serious injury.In accordance with our internal procedures , the assessment of this complaint concludes that the event is a reportable incident as the event has led to a serious injury and surgical intervention was required to prevent a condition requiring hospitalisation i.E.Infection from wound closure over dressing fragments.

Event Description

The following information was received from an end user in (b)(6); "the filler disintegrates during placement, the filler disintegrates during removal.Patient returned to the operating room to remove the filler".The algiante rope ("filler") was applied to an abscess of the anal margin which measured 7cm deep and 1 cm wide.Removal of the filler was not possible by the health care professional as the dressing had disintegrated and as such surgical intervention was required to remove remnant dressing.

• Brand Name: BIATAIN ALGINATE
• Type of Device: 14-2AP ALGINATE CMC DRESSING
• Manufacturer (Section D): ADVANCED MEDICAL SOLUTIONS LTD; premier park, 33 road one; winsford industrial estate; winsford, cheshire 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: 12197029
• MDR Text Key: 262507134
• Report Number: 8044178-2021-00004
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 07/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3 X 44 CM
• Device Catalogue Number: 31374300
• Device Lot Number: W00048031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization