MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2007-10-17 for 628A MIMYX manufactured by Stiefel Laboratories, Inc..
[3892188]
A serious, medically significant spontaneous report regarding a (b)(6) female patient who developed breathing difficulties/severe shortness of breath and experienced increased itching after using mimyx (mimyx). The report was submitted by a consumer. On (b)(6) 2007, at 7pm the patient used mimyx, applied topically for the treatment of itching on arms and legs. Approximately 30-60 minutes later, the patient developed breathing difficulties/severe shortness of breath and increased itching. The patient washed off the product (reported this 'did not help') and applied gold bond. Patient took a shower at 4am - itching and shortness of breath still present after shower. On (b)(6) 2007 treatment with mimyx was discontinued. On (b)(6) 2007 the itching resolved. At the time of the report breathing is improved (almost resolved. Dechallange: positive. Patient stated duration was 'unusual'. The patient's medical history included: myasthenia gravis (diagnosed in 1987) and history of a severe anaphylactic reaction to shellfish 13 years ago (trip to e. R. , required epi, life-threatening).
Patient Sequence No: 1, Text Type: D, B5
[11051939]
Medically significant. Product requested to be returned for testing. The company physician suspected a relationship between the events and mimyx. Further information has been requested.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1314819-2007-01495 |
| MDR Report Key | 3288793 |
| Report Source | 04 |
| Date Received | 2007-10-17 |
| Date of Report | 2007-10-10 |
| Date of Event | 2007-09-17 |
| Date Facility Aware | 2007-09-18 |
| Report Date | 2007-10-10 |
| Date Mfgr Received | 2007-09-18 |
| Date Added to Maude | 2013-08-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVE RICHARDSON, SENIOR DIR. |
| Manufacturer Street | 20 TW ALEXANDER DR. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9199906038 |
| Manufacturer G1 | STIEFEL LABORATORIES, INC. |
| Manufacturer Street | 255 ALHAMBRA CIRCLE STE 100 |
| Manufacturer City | CORAL GABLE FL 33134741 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33134 7412 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 628A MIMYX |
| Generic Name | BARRIER CREAM |
| Product Code | MGQ |
| Date Received | 2007-10-17 |
| Lot Number | T1576 |
| Operator | LAY USER/PATIENT |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STIEFEL LABORATORIES, INC. |
| Manufacturer Address | 255 ALHAMBRA CIRCLE STE 100 CORAL GABLE FL 33134741 US 33134 7412 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-10-17 |