MAUDE Adverse Event Report: CARDINAL HEALTH UNDERPAD, STA-PUT 28''X36''; BEDDING, DISPOSABLE, MEDICAL

Model Number	959
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the underpad breaks when they move the patient.There was no patient harm reported.
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Additional Manufacturer Narrative
Since a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were twelve (12) count of unopened packet of samples provided for the evaluation.Upon analysis, none of the pads contained streaks/stretches in poly and were not dry or brittle.The mats were fully distributed and the side and ends seals were closed.The pads were also viewed under black light by quality assurance technician and engineer, and no issues were found with the hot melt glue.The returned samples met specifications.Therefore, the reported condition is not confirmed, and the root cause of the reported issue could not be determined.At this time, a corrective and preventive action is not deemed necessary.This complaint will be used for qa tracking and trending purposes.

• Brand Name: UNDERPAD, STA-PUT 28''X36''
• Common Device Name: BEDDING, DISPOSABLE, MEDICAL
• Manufacturer (Section D): CARDINAL HEALTH; 525 north emerald rd; greenwood SC 29646
• Manufacturer (Section G): CARDINAL HEALTH; 525 north emerald rd; greenwood SC 29646
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12688933
• Report Number: 1033903-2021-00208
• Device Sequence Number: 17194796
• Product Code: KME
• UDI-Device Identifier: 10884527001231
• UDI-Public: 10884527001231
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2022

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
• Device Model Number: 959
• Device Catalogue Number: 959
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 10/20/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 01/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown