MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-12-27 for STAYFREE SUPER MAXI WITH COTTONY DRY COV NI manufactured by Montreal San Pro.
[3106709]
This spontaneous report was received on (b)(6) 2012, from a (b)(6) female consumer reporting on self from the united states. The medical history included high cholesterol and consumer underwent heart bypass. The concomitant medications included fish oil, vitamin and potassium, all the three medications used one dose each, daily for unspecified indication, unspecified medication one dose for heart disorder, furosemide 40 mg as water pill and lipitor (atorvastatin) one dose for high cholesterol. On (b)(6) 2012, the consumer used stayfree super maxi long, cutaneously, one pad, once for incontinence (lot number 206211670450247, expiration date unspecified). Within thirty minutes, she broke out in rash from head to foot and her throat swelled up. The device was not used further. She consulted a physician. The events were resolving. This report was assessed as serious (medically significant). The company causality was assessed as possible.
Patient Sequence No: 1, Text Type: D, B5
[3152551]
This spontaneous report was received on (b)(6) 2012, from a (b)(6) female consumer reporting on self from the united states. The medical history included high cholesterol and consumer underwent heart bypass. The concomitant medications included fish oil, vitamin and potassium, all the three medications used one dose each, daily for unspecified indication, unspecified medication one dose for heart disorder, furosemide 40 mg as water pill and lipitor (atorvastatin) one dose for high cholesterol. On (b)(6) 2012, the consumer used stayfree super maxi long, cutaneously, one pad, once for incontinence (lot number 206211670450247, expiration date unspecified). Within thirty minutes, she broke out in rash from head to foot and her throat swelled up. The device was not used further. She consulted a physician. The events were resolving. This report was assessed as serious (medically significant). The company causality was assessed as possible. Additional information received on (b)(6) 2013. The lot number was updated from 206211670450247 to 2062m6704. The product name was updated from stayfree super maxi long to stayfree super maxi with cottony dry cover. The consumer consulted a physician and was diagnosed with rash. She was treated with kenalog (triamcinolone) 40 mg and benadryl (diphenhydramine) 25 mg intramuscularly. About two to three days later, the events resolved. No sample was received. Retain sample was visually inspected and no nonconformance or manufacturing defects were observed. Based on the investigation results, due to lack of complaint sample, acceptable documentation review and absence of trends involving stayfree maxi super product family and no trend involving this lot number, there is no evidence to confirm that the device failed to meet the specifications or that a manufacturing issue is the root cause of this complaint. Complaint trends will continue to be monitored. This report remains serious.
Patient Sequence No: 1, Text Type: D, B5
[10491173]
The date of this submission is (b)(4) 2013. This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
[10497645]
(b)(4). This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022269-2012-00163 |
| MDR Report Key | 2888189 |
| Report Source | 04 |
| Date Received | 2012-12-27 |
| Date of Report | 2012-12-12 |
| Date Mfgr Received | 2013-01-10 |
| Date Added to Maude | 2012-12-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMAL YAMANY |
| Manufacturer Street | 199 GRANDVIEW ROAD NI |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089043455 |
| Manufacturer G1 | MONTREAL SAN PRO |
| Manufacturer Street | 7101 RUE NOTRE-DAME E NI |
| Manufacturer City | MONTREAL NI |
| Manufacturer Country | CA |
| Manufacturer Postal Code | NI |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAYFREE SUPER MAXI WITH COTTONY DRY COV |
| Generic Name | MENSTRUAL PADS |
| Product Code | NRC |
| Date Received | 2012-12-27 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | 2062M6704 |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MONTREAL SAN PRO |
| Manufacturer Address | 7101 RUE NOTRE-DAME E NI MONTREAL NI CA NI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-12-27 |