MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-31 for DUREX FOREIGN BRAND CONDOM - UNSPECIFIED manufactured by Reckitt Benckiser.
[66223358]
Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident. The patient did not specify the variety of durex that was used. The patient also did not provide 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 product labelling also states that "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
[66223359]
Initial report, received date: 16-jan-2017, received from consumer relations, country: (b)(6), (b)(4). Suspect product: durex general unspecified condoms. Expiry date: mar-2019. Case reference number (b)(4) is a report sent by a consumer which refers to a male consumer age unknown. It was reported that in 2016; a male consumer age unknown used durex general unspecified condoms, frequency, route, indication, stop date and duration were all unknown. Consumer stated that he was using the condoms for a while at the time of reporting with expiry date mar-2019. Consumer stated that last year 1 condom broke and now he has (b)(6). Consumer stated that during last weekend some other condoms broke again. Consumer stated that he had condoms from 2010 and they were good. The case was deemed serious because it was classed as medically significant due to (b)(6) infection. No further information was available at the time of report. Case assessment of durex general unspecified 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 unknown. Case outcome: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2017-00001 |
| MDR Report Key | 6291534 |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-16 |
| Date Mfgr Received | 2017-01-16 |
| Date Added to Maude | 2017-01-31 |
| 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 070540225 |
| Manufacturer Country | US |
| Manufacturer Postal | 070540225 |
| Manufacturer Phone | 9734042478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DUREX FOREIGN BRAND CONDOM - UNSPECIFIED |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2017-01-31 |
| Device Expiration Date | 2019-03-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RECKITT BENCKISER |
| Manufacturer Address | 399 INTERPACE PARKWAY PARSIPPANY NJ 070540225 US 070540225 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-31 |