MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-25 for TROJAN SUPRA BARESKIN manufactured by Trojan.
[27461797]
Trojan supra bareskin broke during normal vaginal use. No oil or lubricant was used. In an internet search, i see that people are reporting about a 1/3 breakage rate. Please force a recall of this product. We don't need a menopause baby - our family is complete with 2 children. However, what if someone was using this product to prevent the transmission of (b)(6)? If this is not being sent to the appropriate fda department, please forward. Thank you!
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056721 |
| MDR Report Key | 5117779 |
| Date Received | 2015-09-25 |
| Date of Report | 2015-09-25 |
| Date of Event | 2015-09-24 |
| Date Added to Maude | 2015-10-01 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | TROJAN SUPRA BARESKIN |
| Generic Name | CONDOM |
| Product Code | HIS |
| Date Received | 2015-09-25 |
| Device Expiration Date | 2015-09-30 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TROJAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-25 |