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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RECKITT BENCKISER HEALTHCARE INT. LIMITED DUREX ULTRA COMFORT; CONDOM
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RECKITT BENCKISER HEALTHCARE INT. LIMITED DUREX ULTRA COMFORT; CONDOM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aspiration/Inhalation (1725); Fever (1858); Pulmonary Dysfunction (2019); Pulmonary Insufficiency (2022); Foreign Body In Patient (2687)
Event Type  Injury  
Manufacturer Narrative
No action considered necessary for this incident at this point.The patient did not specify the variety of condom that was used.The patient neither provided the batch details for the product nor returned any of the remaining product for quality analysis.No further information is expected; therefore, the company is unable to conduct any further investigation at this moment in time.The company's assessment is serious with a relatedness of possible.
 
Event Description
Case reference number (b)(4) is a literature case report sent by an other health care professional which refers to a female aged (b)(6).It was reported by an other health care professional that on an unknown date, a (b)(6) female patient used unspecified condom; route oral, dose frequency, indication, stop date and duration were all unknown.It was reported that the patient was seen for the complaints of persistent cough, sputum and fever for past six months.There were no other associated symptoms.The general physical and systemic examination were essentially normal.Review of the baseline record did not reveal any gross abnormality in respect of the haematological, biochemical or the radiological profile.Sputum examination for pyogenic organisms and mycobacterium (b)(6) was also (b)(6).The chest radiographs carried out subsequently showed development of a non-homogeneous right upper lobe lesion, not resolving either with antibiotics or a four-month trial of an empirical anti-tuberculosis treatment (att) instituted by various practitioners.No symptomatic relief was obtained with either therapy.During a fresh work-up of the case, no significant abnormality in laboratory parameters was found, but the chest radiograph demonstrated a right upper lobe collapse-consolidation of lung.The opacity led to carry out a video-bronchoscopy, which gave impression of a white membranous object protruding from the collapsed right upper lobe bronchus.On probing further, it was noticed to be an inverted bag-like structure 'sitting' in the bronchus and having a flap-like action.A rigid bronchoscopy was then performed and the object was easily removed with biopsy forceps, though, it tore into pieces during procedure.The pieces were identified as being those of a 'condom'.A bronchial lavage was also carried out.Retrospectively, both the husband and wife accepted that they had undergone a fellatio.They could recollect that the condom had loosened during the act and at that time, the lady had also experienced an episode of sneezing or coughing.A dramatic clinical recovery took place following the bronchoscopic intervention.A progressive radiologic improvement also resulted and the two-week post-bronchoscopy chest radiograph demonstrated a near-complete resolution of the right upper lobe opacity.The patient was advised to come for a monthly follow-up of the residual radiologic opacity.At the time of reporting action taken with the suspect product was unknown and outcome of the case was recovering.The case was deemed serious because it was classed as medically significant due to pyrexia, foreign body aspiration and a condition necessitating medical or surgical intervention to prevent serious deterioration in health.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 unspecified condom 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 unassessable and unknown.Case outcome: recovering / resolving.Case comment: stage of medication error (llt): accidental exposure to product.
 
Event Description
Case reference number (b)(4) is a literature case report sent by an other health care professional which refers to a female aged 27 years.It was reported by an other health care professional that on an unknown date, a 27-year-old female patient used unspecified condom, route oral, dose frequency, indication, stop date and duration were all unknown.It was reported that the patient was seen for the complaints of persistent cough, sputum and fever for past six months.There were no other associated symptoms.The general physical and systemic examination were essentially normal.Review of the baseline record did not reveal any gross abnormality in respect of the haematological, biochemical or the radiological profile.Sputum examination for pyogenic organisms and mycobacterium tuberculosis was also negative.The chest radiographs carried out subsequently showed development of a non-homogeneous right upper lobe lesion, not resolving either with antibiotics or a four-month trial of an empirical anti-tuberculosis treatment (att) instituted by various practitioners.No symptomatic relief was obtained with either therapy.During a fresh work-up of the case, no significant abnormality in laboratory parameters was found, but the chest radiograph demonstrated a right upper lobe collapse-consolidation of lung.The opacity led to carry out a video-bronchoscopy, which gave impression of a white membranous object protruding from the collapsed right upper lobe bronchus.On probing further, it was noticed to be an inverted bag-like structure [?]sitting' in the bronchus and having a flap-like action.A rigid bronchoscopy was then performed and the object was easily removed with biopsy forceps, though, it tore into pieces during procedure.The pieces were identified as being those of a [?] condom'.A bronchial lavage was also carried out.Retrospectively, both the husband and wife accepted that they had undergone a fellatio.They could recollect that the condom had loosened during the act and at that time, the lady had also experienced an episode of sneezing or coughing.A dramatic clinical recovery took place following the bronchoscopic intervention.A progressive radiologic improvement also resulted and the two-week post-bronchoscopy chest radiograph demonstrated a near-complete resolution of the right upper lobe opacity.The patient was advised to come for a monthly follow-up of the residual radiologic opacity.At the time of reporting action taken with the suspect product was unknown and outcome of the case was recovering.The case was deemed serious because it was classed as medically significant due to pyrexia, foreign body aspiration and a condition necessitating medical or surgical intervention to prevent serious deterioration in health.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 unspecified condom 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 unassessable and unknown.Case outcome: recovering / resolving.Case comment: stage of medication error (llt): accidental exposure to product.01-apr-2019: copy of the literature article for this mdr has been obtained and attached.
 
Manufacturer Narrative
No action considered necessary for this incident at this point.The patient did not specify the variety of condom that was used.The patient neither provided the batch details for the product nor returned any of the remaining product for quality analysis.No further information is expected; therefore, the company is unable to conduct any further investigation at this moment in time.The company's assessment is serious with a relatedness of possible.
 
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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
MDR Report Key8453948
MDR Text Key139918850
Report Number3003071219-2019-00002
Device Sequence Number1
Product Code HIS
Combination Product (y/n)N
PMA/PMN Number
K980319
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 03/22/2019
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? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/20/2019
Initial Date FDA Received03/26/2019
Supplement Dates Manufacturer Received02/20/2019
Supplement Dates FDA Received04/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age27 YR
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