MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-03-19 for CAREFREE BODY SHAPE EXTRA LONG CRBSELUS manufactured by Montreal San Pro.
[2544549]
This spontaneous report was received on (b)(6) 2012 from a (b)(6) female consumer reporting on self from (b)(6). The medical history of the consumer included scleroderma since (b)(6), rheumatoid arthritis, reflux, stricture and she was allergic to perfume, cigarette smoke, car exhaust, many chemicals in cleaning supplies, formaldehyde and all scented products. The concomitant medications aspirin twice to thrice a day for twenty years for arthritis and prilosec (omeprazole) fifteen (sic), four times a day for reflux and stricture. On an unspecified date, the consumer started using carefree body shape extra long pantiliners cutaneously, one pad, thrice a day for a little urinary incontinence (off label use) (lot number and expiration date unspecified). After an unspecified duration, she got confused and developed slurred speech, gibberish speak, headache, aggravation of arthritis, swelling of hands and difficulty in bending fingers. She also stated that the device had abnormal smell. She was using the device since ten years. The events resolved after one to three hours. After an unspecified duration, about a month ago, she discontinued the use of device. This report was assessed as serious. The company causality was assessed as possible.
Patient Sequence No: 1, Text Type: D, B5
[9690862]
This closes out this report unless other additional significant information is
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022269-2012-00004 |
| MDR Report Key | 2495092 |
| Report Source | 04 |
| Date Received | 2012-03-19 |
| Date of Report | 2012-02-29 |
| Date Mfgr Received | 2012-02-29 |
| Date Added to Maude | 2012-03-19 |
| 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 | 0 |
| Health Professional | 0 |
| 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 | CAREFREE BODY SHAPE EXTRA LONG |
| Generic Name | MENSTRUAL PADS, SCENTED-DEODORIZED |
| Product Code | NRC |
| Date Received | 2012-03-19 |
| Model Number | CRBSELUS |
| Catalog Number | NI |
| Lot Number | N/A |
| ID Number | NI |
| Operator | LAY USER/PATIENT |
| Device Eval'ed by Mfgr | * |
| 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 | 2012-03-19 |