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

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

Patient Problems Airway Obstruction (1699); Death (1802); Choking (2464)

Event Type  Death  

Manufacturer Narrative

Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident.Reporter did not specify the variety of condom that was used.The reporter also neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis.Therefore, the company is unable to conduct any further investigation at this moment in time.Further information is expected.The company's assessment is serious with relatedness of unassessable and unknown.

Event Description

Initial report, received date 20-feb-2019.Received via literature search, country (b)(6).Suspect product: unspecified condom.Batch no and expiry date: not provided.Case reference number (b)(4) is a spontaneous case report sent by a consumer which refers to a female aged (b)(6).It was reported in a news article by (b)(6) according to (b)(6) law enforcement agencies that a (b)(6) female patient used unspecified condom; route oral, dose, frequency, indication, stop date and duration were all unknown ((b)(6)).Reporter stated that a patient died after she choked on a foreign object.It was reported that the contraceptive device found in her larynx.It was also reported that she choked on a condom when performing oral sex with a man.The condom slipped off the man's reproductive organ during the act and she choked on it as it blocked her airways.Reporter also stated that she died before the ambulance arrived.Pathologists found a crumpled condom in the larynx of the deceased confirming that she died because of an accident.At the time of reporting, action taken with suspect product was not applicable and case outcome was fatal.The patient died from choking and airway obstruction.Death date unknown.The case was deemed serious because it was classed as medically significant due to choking and death.No further information was available at the time of report.Follow-up has been requested to obtain further information.Case assessment for unspecified condom is as follows: the reported serious assessment has not been provided with a relatedness of possible.The company's assessment is serious with a relatedness of unassessable and unknown.Case outcome: fatal.

• Brand Name: DUREX ULTRA COMFORT
• Type of Device: CONDOM
• Manufacturer (Section D): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer (Section G): RECKITT BENCKISER HEALTHCARE INT LIMITED; dansom lane; hull, HU8 7 DS; UK HU8 7DS
• Manufacturer Contact: joanne martinez ; dansom lane; hull, HU8 7-DS ; UK HU8 7DS
• MDR Report Key: 8453861
• MDR Text Key: 139916277
• Report Number: 3003071219-2019-00001
• Device Sequence Number: 1
• Product Code: HIS
• Combination Product (y/n): N
• PMA/PMN Number: K980319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2019
• 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): Death; Other
• Patient Age: 29 YR