MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04,07 report with the FDA on 2015-07-22 for TRIMO SAN MX5030 manufactured by Coopersurgical, Inc..
[6190799]
Consumer diagnosed with urinary tract infection. Reference e-complaint number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[14034086]
Coopersurgical inc. Is currently investigating the reported complaint condition. The device involved in the complaint has not been returned by the customer for evaluation. Once the investigation is completed a follow-up report will be filed. Reference e-complaint number: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2015-00051 |
| MDR Report Key | 4938245 |
| Report Source | 00,04,07 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-07-02 |
| Date of Event | 2015-07-01 |
| Date Mfgr Received | 2015-07-01 |
| Date Added to Maude | 2015-07-30 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DRIVE |
| 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 SAN |
| Generic Name | TRIMO SAN |
| Product Code | KMJ |
| Date Received | 2015-07-22 |
| Model Number | MX5030 |
| Catalog Number | MX5030 |
| Lot 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 | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-22 |