MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2017-12-21 for DUREX BRAND CONDOM (UNSPECIFIC) manufactured by .
[95590699]
The patient has disposed of the product, rb is unable to obtain the lot code and complete quality analysis for this 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 "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. The company's assessment is serious with a relatedness of unassessable / unclassifiable. Corrective action: no action considered necessary for this incident at this point, the company are currently waiting for follow up information regarding the reported incident.
Patient Sequence No: 1, Text Type: N, H10
[95590700]
Initial report, received date: 27-nov-2017. Received from consumer relations, country: (b)(6). Suspect product: durex unspecified 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 male age unknown. It was reported that approximately on (b)(6) 2017, a male patient of an unknown age used durex unspecified condoms, frequency single, dose, indication, route, stop date and duration were all unknown. Patient stated that on?? -??? -2017, after the intercourse, he admitted problems with health. Patient reported that he went to a doctor who diagnosed (b)(6) and he had doctor's conclusion about (b)(6). Patient informed that he had thrown the package out and did not remember what type of condoms he used. At the time of reporting, action taken with the suspect drug was unknown and outcome of the case was not recovered. The case was deemed serious because it was classed as medically significant due to (b)(6). No further information was available at the time of report. Case assessment of durex 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 unassessable / unclassifiable and unknown. Case outcome: not recovered / not resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2017-00009 |
| MDR Report Key | 7140004 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2017-12-21 |
| Date of Report | 2017-12-21 |
| Date Mfgr Received | 2017-11-27 |
| Date Added to Maude | 2017-12-21 |
| 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 TRACY CROOKS |
| 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 BRAND CONDOM (UNSPECIFIC) |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2017-12-21 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | DANSOM LANE HULL, HU8 7DS UK HU8 7DS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-21 |