MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT LIMITED DUREX; CONDOM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abrasion (1689); Aspiration/Inhalation (1725); Hypoxia (1918); Pneumothorax (2012)

Event Type  Death  

Event Description

Case description: initial report, received date 17-may-2019.Received via literature, country south africa.Suspect product: unbranded condom report.Batch no and expiry date: not provided.Case reference number (b)(4) is a literature case report sent by an other health care professional which refers to a male aged (b)(6) years.It was reported by an other health care professional that on an unknown date, a (b)(6)-year-old male patient aspirated condom, dose, frequency, route, indication, stop date and duration were all unknown.Reporter reported that on an unknown date a (b)(6) year-old boy was playing outside alone near a drum that lay on its side.He was found dead by his caregiver.His body was slumped over the drum.Nobody witnessed the circumstances of death.Before the incident, the child had been healthy; there was no family history of cardiac disease.The case was referred for a medico-legal post-mortem examination.Reporter informed that during the autopsy, the child was found to be appropriately grown, weighing (b)(6).Apart from a small, irregular peri-mortal abrasion on the lateral surface of the left chest, there were no signs of injury to the external body.On internal examination of the body, a condom was found at the tracheal bifurcation.The proximal end of the condom was knotted, whereas its distal end was ruptured.The condom was positioned with the knotted end at the tracheal bifurcation and the ruptured end in the lower trachea.Reporter said that both lungs were collapsed; all other organs and the skeleton were normal.The most likely cause of death was acute hypoxia because of the aspirated condom.Further enquiry was made to investigate where the child could have obtained the condom.Prior to the child going out to play, some youths were seen to be playing with condoms.Apparently, they filled them with water, knotted, and ruptured them.These ruptured condoms were discarded and left lying on the ground.The child's anatomy, its development, environmental factors, and the type of foreign object to which it was exposed, all contributed to the likelihood of foreign body aspiration.At the time of report, action taken with suspect product was not applicable and case outcome was fatal.The patient died from acute hypoxia, collapsed lungs and condom aspiration.Death date was unknown.An autopsy was completed on an unknown date, autopsy findings were an irregular peri-mortal abrasion on the lateral surface of the left chest and a condom was found at the tracheal bifurcation.The case was deemed serious because it was classed as medically significant due to hypoxia, pneumothorax, foreign body.No further information was available at the time of report.Required information has been received, follow up is not required by rb at this time.Case assessment for unbranded condom report is as follows: the reported serious assessment has not been provided; case relatedness is possible.The company's assessment is serious with a relatedness of probable and unknown.Case outcome: fatal.

• Brand Name: DUREX
• Type of Device: CONDOM
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, HU87D S; UK HU87DS
• Manufacturer (Section G): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; 399 interpace parkway; parsippany, NJ 07054-0225 ; 9734042478
• MDR Report Key: 8671614
• MDR Text Key: 147088654
• Report Number: 3003071219-2019-00006
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K980319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Death; Other
• Patient Age: 3 YR
• Patient Weight: 14