MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-06-15 for TRIMO SAM MX5030 manufactured by Coopersurgical, Inc..
[21646968]
Patient was fitted for a pessary. Patient later developed a rash believed to be cause by the trimo san gel used in conjunction with the pessary. The patient was given a medication for the rash.
Patient Sequence No: 1, Text Type: D, B5
[21828919]
A review of the complaint database did not indicated any previously reported allergic reactions to trimo san. The patient is said to be a first time wearer. The patient may be allergic to silicone. Silicone allergies are rare. The investigation is currently on going. This report will be supplemented as new information is obtained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2009-00013 |
| MDR Report Key | 1402434 |
| Report Source | 06 |
| Date Received | 2009-06-15 |
| Date of Report | 2009-06-15 |
| Date of Event | 2009-04-30 |
| Date Added to Maude | 2009-06-19 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIMO SAM |
| Generic Name | GEL |
| Product Code | KMJ |
| Date Received | 2009-06-15 |
| Model Number | MX5030 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-06-15 |