N
Patient 1
(B)(4).
MAUDE MDR 8377776
- MDR report key
- 8377776
- Report number
- 1216677-2019-00105
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-02-13
- Date received
- 2019-02-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. PETER NIZIOLEK
- Address
- 75 CORPORATE DRIVE TRUMBULL CT 06611 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TRIMO SAN | TRIMO SAN | COOPERSURGICAL, INC. | HGD | MX5030 | MX5030 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-28 | 0 | 1. O |
Event Narratives#
D
Patient 1
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.