MAUDE Adverse Event Report: COVIDIEN DEVON; SUPPORT, PATIENT POSITION

Model Number 31143384

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Therapeutic Effects, Unexpected (2099); Ulceration (2116)

Event Date 04/06/2018

Event Type  Injury  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reports: the patient presented a small, dry, red (granulating) wound on the anterior of the shin that was covered with a dry dressing.The community nurses used a devon utility pad folded over between the legs to relive some pressure from the area.Within three days the wound over doubled in size and since then has continued to deteriorate and is now down to tendon.

Manufacturer Narrative

No lot number was provided.A review of the device history report (dhr) was unable to be performed.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are in place to prevent nonconforming product in the manufacturing process.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Since no lot number provided, a date of manufacture could not be determined.This product was being used for treatment or diagnosis.Customer provided information also relayed that the nurses say they have now turned the devon pad around using the flat surface against the skin.Employees have reiterated they don¿t encourage this as it is incorrect use and it should be considered removing the pad and finding an alternative.The device was folded over and utilized in a non-conventional method.Standard wound care would not place pressure on a wound.Wounds are typically identified and documented with each visit.Changes to the wound care and appropriate measures should be implemented.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: DEVON
• Type of Device: SUPPORT, PATIENT POSITION
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7742412
• MDR Text Key: 115796917
• Report Number: 1282497-2018-00640
• Device Sequence Number: 1
• Product Code: CCX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31143384
• Device Catalogue Number: 31143384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• 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
• Patient Age: 90 YR