MAUDE Adverse Event Report: COVIDIEN KENDALL; BANDAGE, LIQUID

Model Number 9238

Device Problem Material Fragmentation (1261)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer states that the device disintegrates in filaments on the wound.The filaments should be removed.Pain and trauma of healing and cleaning of the wound occured.

Manufacturer Narrative

Submit date: 12/12/2017.A device history record review of the reported lot number confirmed that the product was produced accomplishing quality requirements and released according to established procedures.Four samples were received and inspection of the sample resulted in no failure.The complaints samples submitted to the lab were evaluated for functionality.The calcium alginate samples were submerged in a saline solution for several minutes and then introduced into more extreme conditions by bringing the solution to its boiling point.The product maintained it integrity.The product did not break apart into fibrous pieces.The cause of this complaint is improper use of the dressing.Calcium alginates are meant to go on heavy exudating wounds so that both the wound and dressing remain moist.If moist, with exudate, the fibers will become gel-like.If dried fibers remain on the wound, it means that it was left on as the wound dried out.In some literature it could also mean that the dressing was changed too quickly and didn¿t have time to form a gel.The wound in the pictures does look dried out or at least not exuding much.Saline solution will also cause the calcium alginate fibers to gel.They are properly or more easily removed if the wound was washed with saline, causing the fibers to gel.Calcium alginate can go from gel to dissolved if properly wet so it can actually absorb into the body.The instructions for use (ifu) does instruct on how to change to ¿lift/remove gelled wound dressing from wound site.Cleanse wound site with wound cleanser or normal saline¿.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.This information will be utilized for trending purposes to determine the need for corrective actions.If information is provided in the future, a supplemental report will be issued.

• Brand Name: KENDALL
• Type of Device: BANDAGE, LIQUID
• Manufacturer (Section D): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer (Section G): COVIDIEN; 1647 perkins rd; augusta GA 30913
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6646987
• MDR Text Key: 77756217
• Report Number: 1018120-2017-05047
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9238
• Device Catalogue Number: 9238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/19/2017
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other