MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-09-11 for DUREX REAL FEEL CONDOM manufactured by Reckitt Benckiser Healthcare Int. Limited.
[119875046]
Rb is awaiting the return of the product for quality analysis and also follow up information regarding the reported incident. Upon reporting the incident the consumer was able to provide details of the product name, batch number and expiry date, therefore enabling rb to review the process records and release testing results from the point of initial manufacture and check retained samples for the specific batch identified. The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[119875047]
Patient had difficulty breathing [dyspnoea], patient's mouth was swollen [mouth swelling], patient had itchy skin [pruritus], patient got an allergic reaction in mouth [hypersensitivity]. Case description: initial report, received date: 20-aug-2018. Received from consumer relations, country: (b)(6), (b)(4). Medical device: durex real feel condom. Batch no. : 100423839. Expiry date: 01-jan-2021. Case (b)(4) is a report sent by a consumer which refers to a male (b)(6). It was reported that on (b)(6) 2018, a (b)(6) male patient used durex real feel condom for an unknown indication. Patient stated that he used the durex real feel on saturday (b)(6) 2018 and got an allergic reaction in his mouth. He stated that it felt like an anaphylactic shock. He stated that his mouth was swollen, difficulty breathing and itchy skin. He stated that he took benadryl and a shower, and he felt better. He said that he was allergic to milk. Treatment had been reported but it was unclear which events were treated. Information received 21-aug-2018, patient stated that he had used the durex real feel condoms a few weeks ago and after putting it on he started to feel itching in his mouth and then when he tried again he had the same reaction in his mouth. He took benadryl with both instances of the reaction, he also stated that the reaction did not last long due to taking the benadryl. This case has been deemed serious due to a condition necessitating medical or surgical intervention to prevent serious deterioration in health. Follow up has been requested to obtain further information. The company's assessment is serious with a relatedness of possible and unanticipated. Case outcome: recovered / resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2018-00011 |
| MDR Report Key | 7865842 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-09-11 |
| Date of Report | 2018-09-09 |
| Date of Event | 2018-08-18 |
| Date Mfgr Received | 2018-08-20 |
| Date Added to Maude | 2018-09-11 |
| 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 |
| 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 REAL FEEL CONDOM |
| Generic Name | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM |
| Product Code | MOL |
| Date Received | 2018-09-11 |
| Lot Number | 100423839 |
| 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. Other | 2018-09-11 |