MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-15 for MXAPP TRIMO SAN JEL-JECTOR manufactured by Coopersurgical, Inc..
[123948921]
(b)(4). The complaint condition reported is currently being investigated. Once the investigation is completed a follow up reported will be filed.
Patient Sequence No: 1, Text Type: N, H10
[123948922]
"patient went to use the applicator and the end was sharp and scrape/cut her on the inside of her vaginal canal. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00052 |
| MDR Report Key | 7966334 |
| Date Received | 2018-10-15 |
| Date of Report | 2018-10-15 |
| Date of Event | 2018-09-25 |
| Date Mfgr Received | 2018-09-25 |
| Date Added to Maude | 2018-10-15 |
| 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 | 50 CORPORATE DRIVE |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 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 | 0 |
| Brand Name | MXAPP TRIMO SAN JEL-JECTOR |
| Generic Name | TRIMO SAN APPLICATOR |
| Product Code | HGD |
| Date Received | 2018-10-15 |
| Model Number | MXAPP |
| Catalog Number | MXAPP |
| Lot Number | UNKNOWN |
| 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 | 2018-10-15 |