MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-03-26 for DUREX ULTRA COMFORT manufactured by Reckitt Benckiser Healthcare Int Limited.
[139916277]
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.
Patient Sequence No: 1, Text Type: N, H10
[139916278]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2019-00001 |
| MDR Report Key | 8453861 |
| Report Source | FOREIGN,LITERATURE |
| Date Received | 2019-03-26 |
| Date of Report | 2019-02-20 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| 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 |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT LIMITED |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal Code | 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 Eval'ed by Mfgr | R |
| 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. Death; 2. Other | 2019-03-26 |