MAUDE Adverse Event Report: COVIDIEN MEDC UPAD 30X36 PREM-CLOTHLIKE; UNDERPAD

Model Number PCL3036

Device Problem Break (1069)

Patient Problems Pain (1994); Burning Sensation (2146); Injury (2348); Numbness (2415)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way.Upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an underpad.The consumer reports that while they were pulling their mother over on the mat, it ripped and the consumer fell into a french door injuring her back on the door handle.The customer further reports having terrible leg and hip pain and her hands are burning and going numb since the incident.The statement was made that she may be needing a emg soon which is a diagnostic test of the muscles and nerve.

Manufacturer Narrative

Submit date: 02/09/2016.Samples were not received and therefore the reported condition has not been observed.This complaint will be re-evaluated if samples are received for review or if more information is provided.Because a manufacturing lot number was not provided by the customer, it was not possible to review the device history record (dhr) for this particular manufacturing day.The most probable root cause was the customer was not informed of the proper repositioning technique to be used with this underpad.Repositioning should be done by four (4) adults, one (1) at each corner of the underpad.Based on the complaint trending information above, our corrective actions are to continue to monitor backsheet material strength.Complaint trending will continue to be monitored and further corrective actions will be implemented if an increase of this reported condition occurs or more information becomes available.

• Brand Name: MEDC UPAD 30X36 PREM-CLOTHLIKE
• Type of Device: UNDERPAD
• Manufacturer (Section D): COVIDIEN; 525 north emerald road; greenwood SC 29646
• Manufacturer (Section G): COVIDIEN; 525 n emerald road; greenwood SC 29646
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5376195
• MDR Text Key: 36236306
• Report Number: 1033903-2016-00001
• 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: consumer,distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PCL3036
• Device Catalogue Number: PCL3036
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2016
• 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