MAUDE Adverse Event Report: COVIDIEN MEDC UPAD 30X36 PREM-CLOTHLIKE; GARMENT, PROTECTIVE, FOR INCONTINENCE

Model Number PCL3036

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported the underpad tore in two pieces when staff were trying to boost a patient into a standing position.The staff member fell backward but was not injured.

• Brand Name: MEDC UPAD 30X36 PREM-CLOTHLIKE
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• 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: 10860047
• MDR Text Key: 218001242
• Report Number: 1033903-2020-00207
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PCL3036
• Device Catalogue Number: PCL3036
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/03/2020
• Type of Device Usage: N
• Patient Sequence Number: 1