MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-04 for SKYN manufactured by Suretex Prophylactics (i), Ltd.
[63912053]
On (b)(6) 2017: a review of the device history record indicates that compounding and manufacturing process were all within specified parameters. Inspection of 13 pieces of retained samples were evaluated for color and odor. No discoloration observed however there was an odor detected on condoms. While odor is subjective from user to user, actions were taken in manufacture processing to decrease discernable odor for this cosmetic complaint.
Patient Sequence No: 1, Text Type: N, H10
[63912054]
On (b)(6) 2016 user indicates that condom sample was discolored and smelled "awful". User indicated that female partner developed symptoms of vaginal infection after using the product. The female partner reached out to her physician who prescribed diflucan for treatment.
Patient Sequence No: 1, Text Type: D, B5
[67675210]
On 01/04/2017 - a review of the device history record indicates that compounding and manufacturing process were all within specified parameters. Inspection of (b)(4) pieces of retained samples were evaluated for color and odor. No discoloration observed however there was an odor detected on condoms. While odor is subjective from user to user, actions were taken in manufacture processing to decrease discernable odor for this cosmetic complaint. On 02/16/2017 - no further correspondence received from end user. No other odor complaint received on the lot# of product. No further action taken aside from what was indicated 1/4.
Patient Sequence No: 1, Text Type: N, H10
[67675211]
(b)(6) 2016 user indicates that condom sample was discolored and smelled "awful". User indicated that female partner developed symptoms of vaginal infection after using the product. The female partner reached out to her physician who prescribed diflucan for treatment.
Patient Sequence No: 1, Text Type: D, B5
[72995575]
01/04/2017 - a review of the device history record indicates that compounding and manufacturing process were all within specified parameters. Inspection of 13 pieces of retained samples were evaluated for color and odor. No discoloration observed however there was an odor detected on condoms. While odor is subjective from user to user, actions were taken in manufacture processing to decrease discernable odor for this cosmetic complaint. On 02/16/2017 - no further correspondence received from end user. No other odor complaint received on the lot# of product. No further action taken aside from what was indicated 1/4 on 03/03/2017 - retain samples from lot were sent microbial testing; results indicated within specification limits. Retain sample from lot were tested for aqueous extractable protein content; results indicated within specification limit. No other action to be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[72995576]
On 12/19/2016 user indicates that condom sample was discolored and smelled "awful". User indicated that female partner developed symptoms of vaginal infection after using the product. The female partner reached out to her physician who prescribed diflucan for treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2017-00002 |
| MDR Report Key | 6223448 |
| Date Received | 2017-01-04 |
| Date of Report | 2017-03-30 |
| Date of Event | 2016-12-13 |
| Date Facility Aware | 2016-12-13 |
| Report Date | 2017-02-16 |
| Date Reported to FDA | 2017-02-16 |
| Date Reported to Mfgr | 2017-01-04 |
| Date Added to Maude | 2017-01-04 |
| 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 |
| Generic Name | SKYN ELITE POLYISOPRENE LUBRICATED CONDOM |
| Product Code | MOL |
| Date Received | 2017-01-04 |
| Lot Number | 1606P20522 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 1 YR |
| 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. Other | 2017-01-04 |