MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-04-25 for DUREX manufactured by Reckitt Benckiser Healthcare Int. Limited.
[106459820]
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 condoms that was used. The patient also did not 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 product labelling states that "no method of contraception can give you 100% protection against pregnancy, hiv or sexually transmitted infections" the company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[106459821]
(b)(6). Case description: initial report, received date: 30-mar-2018. Received from consumer relations, country: (b)(6). Suspect product: durex unknown condoms. 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 age unknown. It was reported that on an unknown date, a female patient of continued in additional info section an unknown age used durex unknown condoms, stop date, duration, indication, route and frequency were all unknown. Patient stated that on?? -??? -2017, since last summer, she was experiencing (b)(6) infection, even when she used rb's condom. At the time of reporting, action taken with the suspect product was unknown and outcome of the case was not recovered / not resolved. The case was deemed serious. No further information was available at the time of report. Case assessment for durex unknown 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: not recovered / not resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2018-00005 |
| MDR Report Key | 7458952 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-04-25 |
| Date of Report | 2018-03-30 |
| Date Mfgr Received | 2018-03-30 |
| Date Added to Maude | 2018-04-25 |
| 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 | 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 |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2018-04-25 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-04-25 |