MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-04 for SKYN 818322 manufactured by Suretex Prophylactics (i), Ltd.
[51224000]
On 08/04/2016 - no information at this time. Internal complaint reference (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[51224001]
Consumer indicated that she had a severe allergic reaction. She went to the doctor and she has a bacterial infection. She indicated to her doctor that she had been using the subject condom before the bacterial infection arose. She has taken antibiotics 3 times alternating between amoxicillin an cipro. She has (b)(6) samples to send back from the box she purchased and which she had used (b)(6). She took one condom to her doctor and the hospital will be doing testing as she is complaining about the odor of the condom and believes that it is a possible source of the infection (according to the user).
Patient Sequence No: 1, Text Type: D, B5
[54642179]
On 08/04/2016 - no information at this time. (b)(4). On 09/12/2016 - the device history record for the lot in question was analyzed and observed that lot was manufactured using synthetic polyisoprene formulation. There was no change in either the raw materials (chemicals) used and/or change of dosage chemicals used in the compounding formulation. All raw materials and the ingredients used in this lot had met all quality requirements during the incoming inspections and were supplied by approved suppliers. The process of condom manufacturing was done as per the documented procedure. Each process output was tested and certified for conformance against the quality plan. The product was lubricated with silicone lubricant as per the brand specification. The lubricant used in the lot is supplied by an approved supplier. No lubricant or dry products were observed during the foiling process and final release inspection and sampling. The batches met the lubricant specification. Retain samples of the lot were sent to external lab for microbial testing. Results indicated that retains within established specification. From the analysis of the dhr, inspection of retain samples, and microbial test reports, no abnormality was found with respect to the lot number associated with this product complaint.
Patient Sequence No: 1, Text Type: N, H10
[54642180]
Consumer indicated that she had a severe allergic reaction. She went to the doctor and she has a bacterial infection. She indicated to her doctor that she had been using the subject condom before the bacterial infection arose. She has taken antibiotics 3 times alternating between amoxicillin an cipro. She has 7 samples to send back from the box she purchased and which she had used one. She took one condom to her doctor and the hospital will be doing testing as she is complaining about the odor of the condom and believes that it is a possible source of the infection (according to the user).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1019632-2016-00006 |
| MDR Report Key | 5847964 |
| Date Received | 2016-08-04 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-07-29 |
| Date Facility Aware | 2016-07-29 |
| Report Date | 2016-08-04 |
| Date Reported to FDA | 2016-08-04 |
| Date Reported to Mfgr | 2016-08-04 |
| Date Added to Maude | 2016-08-04 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | POLYISOPRENE CONDOM |
| Product Code | MOL |
| Date Received | 2016-08-04 |
| Model Number | 818322 |
| Lot Number | 1511P20522 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 6 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. Other | 2016-08-04 |