MAUDE Adverse Event Report: SURETEX PROPHYLACTICS (I), LTD SKYN; POLYISOPRENE CONDOM

Model Number 818322

Device Problem Device Emits Odor (1425)

Patient Problem Bacterial Infection (1735)

Event Date 07/29/2016

Event Type  Injury  

Manufacturer Narrative

On 08/04/2016 - no information at this time.Internal complaint reference (b)(4).

Event Description

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).

Manufacturer Narrative

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.

Event Description

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).

• Brand Name: SKYN
• Type of Device: POLYISOPRENE CONDOM
• Manufacturer (Section D): SURETEX PROPHYLACTICS (I), LTD; 74-91 kiadb estate; jigani ii phase, anekal taluk; bangalore karnataka, bangalore 56210 6; IN 562106
• MDR Report Key: 5847964
• MDR Text Key: 51224000
• Report Number: 1019632-2016-00006
• Device Sequence Number: 1
• Product Code: MOL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/04/2016,09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 818322
• Device Lot Number: 1511P20522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2016
• Distributor Facility Aware Date: 07/29/2016
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 08/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR