MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-02-06 for DUREX PLEASUREMAX manufactured by Reckitt Benckiser.
[66656320]
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 pleasuremax. The patient neither provides 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 "please read the leaflet inside this pack carefully, especially if you are using condoms for anal or oral sex. No method of contraception can give you 100% protection against pregnancy, hiv or sexually transmitted infections. Use a condom only once. " the company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[66656321]
Case description: initial report, received date: 18-jan-2017. Received from consumer relations, country: (b)(6), (b)(4). Medical device: durex settebello classic (product not marketed in usa) batch no and expiry date: not provided. Medical device: durex pleasuremax. (product also marketed in usa). Batch no and expiry date: not provided. Case reference number (b)(4) is a report sent by a consumer which refers to a male age unknown. The case was received from (b)(6). It was reported that on an unknown date, a male patient age unknown used durex settebello classic and durex pleasuremax. He said that the events happened around the end of (b)(6). He had been using durex for longer than 10 years, more or less all of them. When the first episode happened, he was wearing a durex settebello classic, it broke almost at the end of the intercourse right before ejaculating. He said he had another episode happened with pleasure max, it broke during intercourse but without ejaculation at all, he had to do the (b)(6) test after three months, he got the result on (b)(6) 2017, and it was (b)(6). He said he changed brand because due to this two episodes, he was on treatment for huge (b)(6). The company's assessment is serious with a relatedness of possible and unanticipated. Case outcome: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2017-00002 |
| MDR Report Key | 6305811 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-02-06 |
| Date of Report | 2017-01-18 |
| Date of Event | 2016-09-10 |
| Date Mfgr Received | 2017-01-18 |
| Date Added to Maude | 2017-02-06 |
| 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 | MS. JOANNE MARTINEZ |
| Manufacturer Street | 399 INTERPACE PARKWAY |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9734042478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUREX PLEASUREMAX |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2017-02-06 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER |
| Manufacturer Address | 399 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-02-06 |