MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2016-10-19 for DUREX - UNSPECIFIED manufactured by Ssl Manufacturing (thailand) Ltd..
[57985103]
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 that was used. The patient also neither 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. Use a condom only once. Store in a cool dry place away from direct sunlight. No method of contraception can provide 100% protection against pregnancy or the transmission of hiv and stis. If you are worried that you or your partner may have become pregnant or infected, contact your doctor immediately. The company's assessment is serious with a relatedness of possible.
Patient Sequence No: 1, Text Type: N, H10
[57985104]
Condom torn at least twice this year and it caused patient to get sexually transmitted disease [sexually transmitted disease]. Condom torn at least twice this year [device breakage]. Case description: initial report, received date: 17-aug-2016. Received from consumer relations, country: (b)(6). Suspect product: durex unspecified condom. 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 an unknown age used durex unspecified condom, frequency, route, indication, stop date and duration were all unknown. Patient stated that the condom torn at least twice this year (?? -??? -2016) and it had caused her to get a sexually transmitted disease (std) on?? -??? -2016; she also had to take the morning after pill several times. She stated that she thinks the product was unsafe, as she had torn condoms several times over the years. At the time of report, outcome of event was unknown. The case was deemed serious because it was classed as medically significant due to sexually transmitted disease. No further information was available at the time of report. Case assessment for durex unspecified condom, 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: unknown. This case is linked to (b)(4) due to same reporter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2016-00002 |
| MDR Report Key | 6042721 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2016-10-19 |
| Date of Report | 2016-08-17 |
| Date Mfgr Received | 2016-08-17 |
| Date Added to Maude | 2016-10-19 |
| 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 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 - UNSPECIFIED |
| Generic Name | CONDOM, SYNTHETIC |
| Product Code | MOL |
| Date Received | 2016-10-19 |
| 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, CHACHOENGSAO 24180 TH 24180 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-19 |