MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-06-19 for CAREFREE? ACTI-FRESH? BODY SHAPE? TO GO REGULAR 8004100052 manufactured by Montreal San Pro.
[3446320]
This spontaneous report was received on (b)(6) 2013, from a (b)(6) female consumer reporting on self from the united states. The consumer had chemical sensitivity for about seventeen years, was allergic to penicillin and had minor food allergies. The concomitant medications were not reported. On an unspecified date, in the last week, the consumer started using carefree acti-fresh body shape to go regular, cutaneously, one at a time, three times, for feminine hygiene (lot number 0463m8437612:13 and expiration date unspecified). After an unspecified duration she experienced breathing problems like constriction. On the next day, she experienced intestinal abdominal cramps and on the third day the cramps increased and the breathing problem was not getting better. She had diarrhea for the whole weekend and it also affected her digestion. She also stated that she was sick for two days. She stated the label mentioned unscented but she did not see that little asterisk about the odor neutralizer. She discontinued the device about two days ago before reporting. The events were resolving. The report was assessed as serious (medically significant). The company causality was assessed as possible.
Patient Sequence No: 1, Text Type: D, B5
[3615003]
This spontaneous report was received on 03-jun-2013, from a (b)(6) female consumer reporting on self from the united states. The consumer had chemical sensitivity for about seventeen years, was allergic to penicillin and had minor food allergies. The concomitant medications were not reported. On an unspecified date, in the last week, the consumer started using carefree acti-fresh body shape to go regular, cutaneously, one at a time, three times, for feminine hygiene (lot number 0463m8437612:13 and expiration date unspecified). After an unspecified duration she experienced breathing problems like constriction. On the next day, she experienced intestinal abdominal cramps and on the third day the cramps increased and the breathing problem was not getting better. She had diarrhea for the whole weekend and it also affected her digestion. She also stated that she was sick for two days. She stated the label mentioned unscented but she did not see that little asterisk about the odor neutralizer. She discontinued the device about two days ago before reporting. The events were resolving. The report was assessed as serious (medically significant). The company causality was assessed as possible. Additional information received on 10-jul-2013, the lot number was updated from 0463m8437612:13 to 0463m8437. The consumer provided a valid lot number with the complaint. The manufacturer had not received a field sample. Based on the information available, this device was used as intended for treatment. A review of the data associated with the complaint revealed no adverse trends and no trend involving this lot number. The manufacturing and packaging batch record review revealed that the process was executed as per established parameters and procedures. All in-process checks were performed with acceptable results. No incident in regards to process deviations or any atypical situation that may be associated to this type of complaint was observed. Visual inspection of the retain sample met specifications and no nonconformance or manufacturing defects were observed related to this complaint. No issues were recorded related to this complaint. Based on the investigation results, no assignable cause was identified. Complaint trends would continue to be monitored. The report remains as serious.
Patient Sequence No: 1, Text Type: D, B5
[10850846]
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
[10959745]
The date of this submission is 26-jul-2013. This closes out this report unless other additional significant information is received.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8022269-2013-00050 |
| MDR Report Key | 3176683 |
| Report Source | 04 |
| Date Received | 2013-06-19 |
| Date of Report | 2013-06-03 |
| Date Mfgr Received | 2013-07-10 |
| Date Added to Maude | 2013-06-19 |
| 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 | 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 | CAREFREE? ACTI-FRESH? BODY SHAPE? TO GO REGULAR |
| Generic Name | MENSTRUAL PADS, SCENTED-DEODORIZED |
| Product Code | NRC |
| Date Received | 2013-06-19 |
| Model Number | 8004100052 |
| Catalog Number | NI |
| Lot Number | 0463M8437 |
| 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 | 2013-06-19 |