MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-20 for SKYN POLYISOPRENE MALE CONDOM manufactured by Suretex Prophylactics (i), Ltd..
[58016035]
On 10/20/2017: user contacted ansell on (b)(6) 2016 indicated a reaction issue with product without further information to the reaction. Email correspondence to the end user seeking more information on the incident was responded on (b)(6) 2016 to indicated that one month earlier he and his girlfriend used a condom and later in the month, another condom, and both time the partner developed a urinary tract infection. Ansell was advised that partner was prescribed macrobid for the infection.
Patient Sequence No: 1, Text Type: N, H10
[58016036]
On 10/20/2017: user contacted ansell on (b)(6) 2016 indicated a reaction issue with product without further information to the reaction. Email correspondence to the end user seeking more information on the incident was responded on (b)(6) 2016 to indicated that one month earlier he and his girlfriend used a condom and later in the month, another condom, and both times the partner developed a urinary tract infection. Ansell was advised that partner was prescribed macrobid for the infection.
Patient Sequence No: 1, Text Type: D, B5
[61254630]
On 10/20/2016 - user contacted ansell on 9/13/2016 indicated a reaction issue with product without further information to the reaction. Email correspondence to the end user seeking more information on the incident was responded on 10/13/2016 to indicated that one month earlier he and his girlfriend used a condom and later in the month, another condom, and both time the partner developed a urinary tract infection. Ansell was advised that partner was prescribed macrobid for the infection. On 12/01/2016: device history record of the lot was analyzed with respect to the reported complaint. The lot was produced using synthetic polyisoprene with existing compounding formulation and there is no change in dosage or change of raw materials and chemicals used. There is also no change in chemicals used in the various stages of the manufacturing process. The lot was inspected at various stages of manufacturing process and released as per the documented quality plan. Each process output was tested and verified for conformance against the quality plan. The lot was lubricated with silicone lubricant as per the brand specification. The lubricant used in the lot is supplier by an approved supplier. Lot no: 1601p21622, in process lubricant qty (mg): min: 480, max: 560, mean: 553. Finished product lubricant qtw (mg): min: 511, max:587. No lubricant and dry products were observed during the foiling process and final release inspection and sampling. The batches met the lubricant specification inspection of retained samples: 13 pcs of retained samples were tested for microbial testing. All the sample results are within the microbial test specification: (b)(6). Inspection of customer returned samples. Ten (10) pcs returned and test for lubricant qty 1601p21622: min: 490, max: 563, mean: 5528. No anomalies determined; no assignable cause can be found from customer returned samples. No further action can be taken.
Patient Sequence No: 1, Text Type: N, H10
[61254631]
On 10/20/2016 - user contacted ansell on (b)(6) 2016 indicated a reaction issue with product without further information to the reaction. Email correspondence to the end user seeking more information on the incident was responded on 10/13/2016 to indicated that one month earlier he and his girlfriend used a condom and later in the month, another condom, and both time the partner developed a urinary tract infection. Ansell was advised that partner was prescribed macrobid for the infection. On 12/01/2016 - user sent samples in for investigation on 10/24/2016 which as sent on the manufacturing facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2016-00010 |
| MDR Report Key | 6045113 |
| Date Received | 2016-10-20 |
| Date of Report | 2016-12-01 |
| Date of Event | 2016-09-13 |
| Date Facility Aware | 2016-09-13 |
| Report Date | 2016-10-20 |
| Date Reported to FDA | 2016-10-20 |
| Date Reported to Mfgr | 2016-10-20 |
| Date Added to Maude | 2016-10-20 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SKYN POLYISOPRENE MALE CONDOM |
| Generic Name | SYNTHETIC POLYISOPRENE MALE CONDOM |
| Product Code | MOL |
| Date Received | 2016-10-20 |
| Returned To Mfg | 2016-10-24 |
| Lot Number | 1601P21622 |
| Device Expiration Date | 2019-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | 9 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX PROPHYLACTICS (I), LTD. |
| Manufacturer Address | 74-91 KIADB INDUSTRIAL ESTATE JIGANI PHASE, ANEKAL TALUK BANGALORE, IN-KA 560105 IN 560105 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-20 |