MAUDE Adverse Event Report: COVIDIEN UNDERPAD 30INX36IN WINGS QUILTED; BEDDING, DISPOSABLE, MEDICAL

Model Number	P3036C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation as it has been discarded; 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.
Event or Problem Description
The customer reported that the underpad ripped when turning a (b)(6) pound male patient.

• Brand Name: UNDERPAD 30INX36IN WINGS QUILTED
• Common Device Name: BEDDING, DISPOSABLE, MEDICAL
• Manufacturer (Section D): COVIDIEN; 525 north emerald rd; greenwood SC 29646
• MDR Report Key: 9682157
• Report Number: 1033903-2020-00205
• Device Sequence Number: 3445792
• Product Code: KME
• UDI-Device Identifier: 10884521141803
• UDI-Public: 10884521141803
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: P3036C
• Device Catalogue Number: P3036C
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2020
• Initial Report FDA Received Date: 02/07/2020
• Patient Sequence Number: 1
• Patient Weight: 57