MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SWAB,ORAL,DENTIPS,UNTREAT,INDV WRP,BLUE

Catalog Number MDS096202

Device Problem Disconnection (1171)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/09/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a client clamped down on the dentips and the whole foam piece became disconnected from the stick.The facility reported that the client swallowed the foam and the foam was in the client's airway.No distress was noted.The staff was able to get the client to cough up the foam piece and remove the foam from his mouth without further incident.No further intervention was required.There are no photos available and the actual sample was disposed of.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a client clamped down on the dentips and the whole foam piece became disconnected from the stick.The facility reported that the client swallowed the foam and the foam was in the clients airway.No distress was noted.The staff was able to get the client to cough up the foam piece and remove the foam from his mouth without further incident.

• Type of Device: SWAB,ORAL,DENTIPS,UNTREAT,INDV WRP,BLUE
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 12325173
• MDR Text Key: 266680451
• Report Number: 1417592-2021-00159
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS096202
• Device Lot Number: 41220120001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 90