MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2019-04-02 for DUREX manufactured by Reckitt Benckiser Healthcare Int Limited.
[140734040]
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 natural feeling condoms. The patient neither provided the batch details for the product nor returned any of the remaining unopened product for quality analysis. Further information is expected. The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[140734041]
Case description: initial report, received date: 09-mar-2019. Received from consumer relations, country: (b)(6), reference no: (b)(4). Medical device: durex natural feeling 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 on an unknown date, a male patient of an unknown age used durex natural feeling condoms for an unknown indication. Patient reported that on unknown date, product had caused the allergic reaction. Patient stated that usage of the condom lead to an emergency stay in the hospital. The patient was admitted to the hospital, admittance date, discharge date, days in hospital were all unknown. The case was deemed serious because it was classed as medically significant due to hypersensitivity and hospitalisation. Follow up has been requested to obtain further information. 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 | 3003071219-2019-00003 |
| MDR Report Key | 8476142 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2019-04-02 |
| Date of Report | 2019-03-29 |
| Date Mfgr Received | 2019-03-09 |
| Date Added to Maude | 2019-04-02 |
| 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, HU8 7DS |
| Manufacturer Country | UK |
| Manufacturer Postal | 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 | 2019-04-02 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Hospitalization; 2. Other | 2019-04-02 |