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

Model Number P3036PS

Device Problem Off-Label Use (1494)

Patient Problems Adult Respiratory Distress Syndrome (1696); Swelling (2091); Vomiting (2144)

Event Date 09/05/2019

Event Type  Injury  

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 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
• 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: 9142196
• MDR Text Key: 163116298
• Report Number: 1033903-2019-00204
• Device Sequence Number: 1
• Product Code: KME
• UDI-Device Identifier: 10884521155299
• UDI-Public: 10884521155299
• 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: Other
• Type of Report: Initial
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P3036PS
• Device Catalogue Number: P3036PS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other