MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SYRINGE, EAR, REINER, COMPLETE, 50CC

Catalog Number MDS4409650

Device Problem Break (1069)

Patient Problems Abrasion (1689); Nausea (1970); Pain (1994); Numbness (2415)

Event Date 04/29/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that while in use during an ear cerumen debridement procedure, the tip of the ear syringe broke off into the patient's upper ear canal.Reportedly, the patient experienced "pain, inflammation, an abrasion, temporary left sided facial numbness and mild bleeding to the left ear." it is unknown how much fluid was inside of the ear syringe at the time of the incident.Approximately one (1) week after the reported incident, the patient was reportedly prescribed an unidentified narcotic medication and ibuprofen for pain control, phenergan for nausea, and unidentified antibiotic ear drops.No further medical treatment or follow-up care was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported product issue could not be determined.Due to the reported need for medical treatment, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the tip of the ear syringe broke off during use.The patient required medical treatment.

• Type of Device: SYRINGE, EAR, REINER, COMPLETE, 50CC
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8637433
• MDR Text Key: 146664032
• Report Number: 1417592-2019-00075
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS4409650
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 33 YR
• Patient Weight: 77