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U.S. Department of Health and Human Services

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

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RECKITT BENCKISER HEALTHCARE INT LIMITED DUREX CONDOM Back to Search Results
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.
 
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Brand NameDUREX
Type of DeviceCONDOM
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 Key8671614
MDR Text Key147088654
Report Number3003071219-2019-00006
Device Sequence Number1
Product Code HIS
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K980319
Number of Events Reported1
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 Received06/05/2019
Is this an Adverse Event Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2019
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 Unkown

Patient Treatment Data
Date Received: 06/05/2019 Patient Sequence Number: 1
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