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

Model Number P3036C

Device Problems Improper or Incorrect Procedure or Method (2017); Torn Material (3024)

Patient Problems Fall (1848); Pain (1994); Injury (2348)

Event Date 04/13/2015

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with an underpad.The customer states the nurse was using the underpad to lift and re-position the patient when the pad ripped causing the nurse to fall backwards into the wall and injure her back.The nurse went to the er for pain medication and received toradol.

Manufacturer Narrative

Submit date: 4/21/2015.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.If samples are received at a later date, this complaint will be re-opened and the investigation continued.Testing was performed on representative samples for tensile and burst strengths were found to be within specification.The most probable root cause could be due to the repositioning technique used with the underpad.The manufacturing plant will continue to examine back sheet material and test past and current products.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 road; greenwood SC 29646
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4715124
• MDR Text Key: 5579738
• Report Number: 1033903-2015-00002
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• 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: 08/04/2015
• 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