MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-18 for DUREX REAL FEELING manufactured by Ssl Manufacturing (thailand) Ltd..
[57876898]
Reckitt benckiser 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 and batch number, 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. 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. Use a condom only once. " the company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[57876899]
(b)(6); wounds [wound]; condom broke [device breakage]. Initial report, received date: 27-sep-2016. Received from consumer relations, country: (b)(6). Case reference number (b)(4) is a report sent by a consumer which refers to a female age unknown. It was reported that on (b)(6) 2016 (two days before reporting), a female patient age unknown used durex real feeling. She said months before reporting, she had a sexual intercourse and the condom broke. She said nothing at the time. Two days before reporting, she had the same problem-the condom broke. The problem was that she went to the gynecologist and he diagnosed the (b)(6). She said that it might because the condom broke months before reporting. She said she had to be operated to remove wounds because of the (b)(6). Foreign case, no udi. (b)(4). The company's assessment is serious with a relatedness of possible and unanticipated. Case outcome: unknown. The case is linked to (b)(4) due to same reporter. Case comment: reporter's assessment: diagnosis: (b)(6) viral infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2016-00001 |
| MDR Report Key | 6038215 |
| Date Received | 2016-10-18 |
| Date of Report | 2016-09-27 |
| Date of Event | 2016-09-25 |
| Date Mfgr Received | 2016-09-27 |
| Date Added to Maude | 2016-10-18 |
| 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 Phone | 4042478 |
| Manufacturer G1 | RECKITT BENCKISER HEALTHCARE INT LIMITED |
| 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 | 0 |
| Brand Name | DUREX REAL FEELING |
| Generic Name | CONDOM, SYNTHETIC |
| Product Code | MOL |
| Date Received | 2016-10-18 |
| Lot Number | 1000113316 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SSL MANUFACTURING (THAILAND) LTD. |
| Manufacturer Address | WELLGROW INDUSTRIAL ESTATE 100 MOO 5, BANGNA-TRAD KM 36 BANGSAMAK, BANPAKONG, CHACHOENGSA 24180 TH 24180 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-18 |