N
Patient 1
ADDITIONAL TESTING OF RESERVE SAMPLES MET ACCEPTANCE CRITERIA.
MAUDE MDR 8605850
- MDR report key
- 8605850
- Report number
- 2249852-2019-00011
- Event key
- 0
- Event type
- 3
- Date received
- 2019-05-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. GLORIA ZUCLICH
- Address
- 15 THORNTON ROAD OAKLAND NJ 07436 US
- Phone
- 201-201-2014
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COLLAGEN DENTAL MEMBRANE | COLLAGEN MATRIX, INC. | NPL | CM3040 | CMN18K6 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-13 | 0 | 1. O |
Event Narratives#
D
Patient 1
A DISTRIBUTOR ADVISED THAT A CLINICIAN REPORTED TO HAVE HAD A PATIENT COME DOWN WITH AN INFECTION. BASED ON LIMITED CORRESPONDENCE, THE CLINICIAN MAY HAVE USED PORTIONS OF ONE MEMBRANE ON SEVERAL PATIENTS. AS PER THE IFU, THIS PRODUCT IS FOR SINGLE USE ONLY AND OPEN, UNUSED PRODUCT MUST BE DISCARDED. IT IS UNKNOWN IF THE PRODUCT WAS REMOVED OR REPLACED, OR IF THERE WAS ANY ADDITIONAL TREATMENT TO RESOLVE THE REPORTED INFECTION.