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

Model Number P3036C

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2020

Event Type  malfunction  

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 Description

The customer reported that the underpad ripped when turning a (b)(6) pound male patient.

• Brand Name: UNDERPAD 30INX36IN WINGS QUILTED
• Type of Device: BEDDING, DISPOSABLE, MEDICAL
• Manufacturer (Section D): COVIDIEN; 525 north emerald rd; greenwood SC 29646
• Manufacturer (Section G): COVIDIEN; 525 north emerald rd; greenwood SC 29646
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 9682157
• MDR Text Key: 191377929
• Report Number: 1033903-2020-00205
• Device Sequence Number: 1
• Product Code: KME
• UDI-Device Identifier: 10884521141803
• UDI-Public: 10884521141803
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3036C
• Device Catalogue Number: P3036C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 57