MAUDE Adverse Event Report: COVIDIEN WINGS QUILTED PREMIUM STRENGTH 30X36; BEDDING, DISPOSABLE, MEDICAL

Model Number	P3036PS
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Swelling (2091); Vomiting (2144)
Date of Event	09/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A lot number was not provided, as a result the device history record review 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.Samples were not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and determine the root cause.If the sample is returned in the future, this complaint will be re-opened for further investigation.No formal investigation is being conducted as the pad was used in a manner not designed for use.Management personnel will be notified of this complaint.Complaint trending will continue to be monitored and corrective actions will be evaluated if an increase of this failure mode occurs.
Event or Problem Description
The customer reported that a patient in the hospital ate the underpad.Per the doctor, the patient stated that he could not breathe and the patient was vomiting up little pellets.Additional information provided on 09-sep-2019 stated the patient¿s stomach swelled after eating the product.The patient is doing better after profuse vomiting of the substance but the stomach swelling is still visible.The doctor is keeping the patient hydrated to try to reduce the stomach swelling.

• Brand Name: WINGS QUILTED PREMIUM STRENGTH 30X36
• Common Device Name: BEDDING, DISPOSABLE, MEDICAL
• Manufacturer (Section D): COVIDIEN; 525 north emerald rd; greenwood SC 29646
• MDR Report Key: 9142196
• Report Number: 1033903-2019-00204
• Device Sequence Number: 2184083
• Product Code: KME
• UDI-Device Identifier: 10884521155299
• UDI-Public: 10884521155299
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: P3036PS
• Device Catalogue Number: P3036PS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 10/01/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other