MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for SKYN POLYISOPRENE CONDOM 123625 manufactured by Suretex Prophylactics (i), Ltd.
[68665969]
On 03/01/2017 - after an indication of customer infection requiring medical treatment on (b)(6), initial report filing. Manufacturing has reviewed the device history record. No out of specification or in process deviations noted. Product was released consistent with all internal specifications. Retained samples did indicate a slight odor. In 2016 - to decrease the odor profile, modification to the in line leaching process, ex dip washing, and odor masking agent were introduced to alleviate the cosmetic odor of the condoms.
Patient Sequence No: 1, Text Type: N, H10
[68665970]
On 03/01/2017 - customer indicated that upon opening the product, the product had a "foul smell". Several other foiled products from the same carton had the same smell. Customer indicated on (b)(6) that partner had an infection and sought medical attention for treatment of infection.
Patient Sequence No: 1, Text Type: D, B5
[75024423]
On 03/01/2017 - after an indication of customer infection requiring medical treatment on (b)(6), initial report filing. Manufacturing has reviewed the device history record. No out of specification or in process deviations noted. Product was released consistent with all internal specifications. Retained samples did indicate a slight odor. In 2016 - to decrease the odor profile, modification to the in line leaching process, ex dip washing, and odor masking agent were introduced to alleviate the cosmetic odor of the condoms. On 05/02/2017: > a review of the device history record indicated that the product was manufactured and processed within specification. No deviations were noted in the production record. > > micro testing of retain samples indicated that samples were within test specifications > protein testing of retained samples were evaluated and are within acceptable limit. > returned samples from customer were inspected and slight odor was detected. > a masking agent along with process enhancements for leaching process in production to lessen this cosmetic aesthetic was cleared under a 510k has since been implemented and is to be shipped by end of june 2017. No other actions to take place.
Patient Sequence No: 1, Text Type: N, H10
[75024444]
On 03/01/2017 - customer indicated that upon opening the product, the product had a "foul smell". Several other foiled products from the same carton had the same smell. Customer indicated on (b)(6) that partner had an infection and sought medical attention for treatment of infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00005 |
| MDR Report Key | 6368476 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-05-02 |
| Date of Event | 2017-01-17 |
| Date Facility Aware | 2017-01-17 |
| Report Date | 2017-03-01 |
| Date Reported to FDA | 2017-03-01 |
| Date Reported to Mfgr | 2017-03-01 |
| Date Added to Maude | 2017-03-01 |
| 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 CONDOM |
| Generic Name | POLYISOPRENE CONDOM |
| Product Code | MOL |
| Date Received | 2017-03-01 |
| Catalog Number | 123625 |
| Lot Number | 1606P40922 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURETEX PROPHYLACTICS (I), LTD |
| Manufacturer Address | 74-91 KIADB ESTATE JIGANI II PHASE, ANEKAL TALUK BANGALORE KARNATAKA, BANGALORE 562106 IN 562106 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-01 |