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

Model Number P3036C

Device Problem Torn Material (3024)

Patient Problems Fall (1848); Injury (2348)

Event Date 03/31/2015

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 that when the nurse went to lift and reposition a patient who weighed around 250lbs, the edge of the pad ripped and she fell backwards against other equipment in the patients room causing back injury.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.Mansfield product monitoring has contacted the customer on (b)(4) 2015.The hospital contact advised that they cannot provide clinical / patient information due to (b)(6)regulations; however, they did state that there was an injury and it was treated.They have also advised that no additional information will be provided.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was received for evaluation.A tear was observed on the sample.Testing was performed on the returned sample and tensile and burst strengths were found to be within specifications.The most probable root cause can be due to the repositioning technique that was 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.If additional information is received at a later date, this complaint will be re-opened and the investigation continued.

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.

• 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: 4690179
• MDR Text Key: 5715646
• Report Number: 1033903-2015-00001
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2015
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other