MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2014-12-04 for LIFESTYLES UNK manufactured by Unk.
[22226241]
(b)(4). - ansell healthcare products llc is submitting this report on behalf of unk mfr.
Patient Sequence No: 1, Text Type: N, H10
[22268188]
The customer informed ansell healthcare products, llc that after using a lifestyles condom that contained spermicide nonoxynol-9 he received a severe skin burn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2014-00016 |
| MDR Report Key | 4309898 |
| Report Source | 04 |
| Date Received | 2014-12-04 |
| Date of Report | 2014-12-04 |
| Date Facility Aware | 2014-12-02 |
| Report Date | 2014-12-04 |
| Date Reported to FDA | 2014-12-04 |
| Date Mfgr Received | 2014-12-02 |
| Date Added to Maude | 2014-12-10 |
| 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 |
| Manufacturer Street | 1635 INDUSTRIAL RD. |
| Manufacturer City | DOTHAN AL 36303 |
| Manufacturer Country | US |
| Manufacturer Postal | 36303 |
| Manufacturer Phone | 3346152566 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESTYLES |
| Generic Name | UNK |
| Product Code | LTZ |
| Date Received | 2014-12-04 |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-12-04 |