MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC. J & J BABY SAFETY COTTON SWABS; APPLICATOR ABSORBENT TIPPED, NON-STERILE

Device Problems Break (1069); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Material Perforation (2205)

Patient Problems Hearing Impairment (1881); Hearing Loss (1882); Unspecified Infection (1930); Rupture (2208); Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)

Event Date 01/01/2009

Event Type  Injury  

Event Description

This spontaneous report was received from a female patient of unknown age reporting on self from the united states: (b)(4).The patient¿s medical history, height and weight were not reported.On an unspecified date, the patient started using johnson and johnson baby safety cotton swabs unspecified (auricular, dose and frequency unspecified) used for unknown indication.The concomitant medications were not reported.Patient, (b)(6).On an unspecified date, the patient's eardrum got ruptured and was deaf in ear (hearing impaired).On an unspecified date, she went to the hospital and had vertigo and she lost her id.Action taken with johnson and johnson baby safety cotton swabs unspecified was unknown.The outcome of vertigo, deaf (hearing impaired) and eardrum ruptured was unknown.This report was not serious.Follow up information was received on 01-aug-2018.This report contained no new regulatory relevant information.No changes were made to the report.Version 2 created to amend previously reported information on 01-aug-2018.Upon review following corrections were made.The event deaf in ear (hearing impaired) updated to deafness.Seriousness of events deafness and eardrum ruptured updated from non-serious to serious.Case priority updated from p5 to p2.Case seriousness updated from non-serious to serious (medically significant).Additional medically relevant information was received from patient on 08-jan-2019.Upon review following correction was performed along with follow up information: on an unspecified date, the patient started using johnson and johnson baby safety cotton swabs unspecified q-tip (auricular, frequency unspecified) used for unknown indication in her ear (intentional product misuse).The patient reported that she sustained an injury after using the johnson's cotton swabs.On an unspecified date in 2009, the ear drum was infected, got ruptured, developed vertigo and the patient was on wheelchair since last 3 years and hence was not able to work; the q-tip was broken as it was faulty (product quality issue) and went up into her brain (foreign body), the other half fell on the floor.It was also reported that the q-tip was lodged into brain and experienced deafness in the left ear (totally deaf).On an unspecified date, the patient went to emergency room for vertigo and was admitted there.On an unspecified date, the patient went to the hearing specialist and they told that there was nothing more to do and underwent hearing test with unspecified results.The patient tried hearing aid but it did not help.It was also reported that the patient used walker along with wheel chair as a part of treatment.The patient had not recovered for left ear deafness, foreign body, vertigo and outcome was unknown for product quality issue; intentional product misuse, ear drum rupture and ear drum infection.This report was associated with the product complaint and product complaint number was (b)(4).This report was serious (medically significant and disabling/incapacitating).Date received by mfr: 01/08/2019.Adverse event term: membrane perforation and myringitis.

• Brand Name: J & J BABY SAFETY COTTON SWABS
• Type of Device: APPLICATOR ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC.
• MDR Report Key: 8290571
• MDR Text Key: 135023439
• Report Number: MW5083514
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/21/2019

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?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability