MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2017-11-22 for DUREX PERFORMA manufactured by Reckitt Benckiser Healthcare Int. Limited.
[92833030]
Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident. The patient did specify the variety of durex that was used as durex performa condoms. The patient also neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis. Further information is expected. The product labelling also states that "if you or your partner experiences breathing difficulties, or gets blue lips when using these condoms, stop using them immediately and call a doctor. Please read the leaflet inside this pack carefully, especially if you are using condoms for non-vaginal sex. Use a condom only once. The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[92833031]
Patient lips were blue [cyanosis]. Patient did not have any feeling in mouth [hypoaesthesia oral] bitter taste [dysgeusia]. Case description: received from consumer relations, country (b)(6), reference no: (b)(4). Suspect product: durex performa condoms. Case reference number de-(b)(6) is a spontaneous case report sent by a consumer which refers to a female age unknown. It was reported that on an unknown date a female patient of an unknown age used durex performa condoms, frequency, route, indication, stop date and duration were all unknown. Patient stated that her boyfriend used the durex performa condoms from the durex fun explosion pack and during intercourse everything was fine. However, when we spontaneously switched to oral sex again, the bitter taste made me startled. Patient's lips were blue and she did not have any feeling in her mouth. The case was deemed serious because it was classed as medically significant due to cyanosis. No further information was available at the time of report. Case assessment of durex performa condoms 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 possible and unlisted. Case outcome: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2017-00007 |
| MDR Report Key | 7054829 |
| Report Source | CONSUMER |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-22 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-11-22 |
| 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, HULL HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | HU8 7DS |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT. LIMITED |
| Manufacturer Street | DANSOM LANE |
| Manufacturer City | HULL, 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 PERFORMA |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2017-11-22 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| 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, HULL HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-22 |