MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-02-28 for TRIMO SAN MX5030 manufactured by Coopersurgical, Inc..
[137397673]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[137397674]
Patient states they are allergic to the trim-san jelly. Advised she purchased at (b)(6). Patient was advised to contact their medical provider to alert of any adverse effects. Patient states they have no interest in doing so. Patient only looking for reimbursement of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2019-00105 |
| MDR Report Key | 8377776 |
| Report Source | USER FACILITY |
| Date Received | 2019-02-28 |
| Date of Event | 2019-02-13 |
| Date Mfgr Received | 2019-02-13 |
| Date Added to Maude | 2019-02-28 |
| 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 | 3 |
| Manufacturer Contact | MR. PETER NIZIOLEK |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 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 | HGD |
| Date Received | 2019-02-28 |
| Model Number | MX5030 |
| Catalog Number | MX5030 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-28 |