MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-05-22 for DUREX THIN FEEL manufactured by Reckitt Benckiser Healthcare Int. Limited.
[108975106]
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 batch number, product name and expiry date was not provided, 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 product labelling also states that "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 possible.
Patient Sequence No: 1, Text Type: N, H10
[108975107]
Sexually transmitted disease [sexually transmitted disease]. Product left at risk of pregnancy [pregnancy with contraceptive device] left approximately a quarter of the condom in situ [complication associated with device] condom broke during use [device breakage] case description: initial report, received date 25-apr-2018. Received from consumer relations, country (b)(6), reference no: (b)(4). Suspect product: durex thin feel batch no: 1000274744. Case reference number (b)(6) 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 thin feel condom, frequency, route, indication, stop date and duration were all unknown. Patient stated that a condom from lot 1000274744 broke during use and left approximately a quarter of the condom in situ resulting in a trip to her nurse to have this removed. Patient stated that the product had left her at risk of pregnancy and also std (sexually transmitted disease) which was the reason for use. Patient also stated that she had now been left exposed to a lifelong condition and have had to be prescribed antibiotics as well a second medication. This case has been deemed serious because it was classed as medically significant due to sexually transmitted disease and permanent impairment of a body function or permanent damage to a body structure. No further information was available at the time of report. Case assessment of durex thin feel 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 probable and unknown. Case outcome: unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003071219-2018-00006 |
| MDR Report Key | 7535674 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-05-22 |
| Date of Report | 2018-05-22 |
| Date Mfgr Received | 2018-04-25 |
| Date Added to Maude | 2018-05-22 |
| 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 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 THIN FEEL |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2018-05-22 |
| Lot Number | 1000274744 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-05-22 |