MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-03-26 for DUREX ULTRA COMFORT manufactured by Reckitt Benckiser Healthcare Int. Limited.
[139918850]
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.
Patient Sequence No: 1, Text Type: N, H10
[139918851]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2019-00002 |
| MDR Report Key | 8453948 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,L |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-22 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOANNE MARTINEZ |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUREX ULTRA COMFORT |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2019-03-26 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Address | DANSOM LANE HULL, HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-26 |