MAUDE Adverse Event Report: COVIDIEN WINGS QUILTED CLOTH-LIKE 30X36; UNDERPAD

Model Number P3036C

Device Problems Break (1069); Material Separation (1562)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/05/2015

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with an under pad.The customer states that while repositioning a patient, approximately (b)(6)., the under-pad ripped causing a nurse to injure her hand.The patient was fine, but in the process of the pad tearing, the nurse injured her hand and it was reported to be fractured.The nurse left work and went to occupational health.

Manufacturer Narrative

Submit date: (b)(6) 2015.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.Testing was performed for tensile and burst strengths on a range of product lots to verify old and new products are all in alignment.Certificate of analysis data was reviewed for the back sheet material and all found to be well within specifications.A possible root cause could be due to the repositioning technique that was used with this under pad.As part of a corrective action, instructions for use will be implemented for this product.This complaint will be used for tracking and trending purposes.

• Brand Name: WINGS QUILTED CLOTH-LIKE 30X36
• Type of Device: UNDERPAD
• Manufacturer (Section D): COVIDIEN; 525 north emerald road; greenwood SC 29646
• Manufacturer (Section G): COVIDIEN; 525 north emerald rd; greenwood SC 29646
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4783202
• MDR Text Key: 5878839
• Report Number: 1033903-2015-00003
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P3036C
• Device Catalogue Number: P3036C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other