N
Patient 1
DEVICE NOT RETURNED TO MANUFACTURER.
MAUDE MDR 4921688
- MDR report key
- 4921688
- Report number
- 0001038806-2015-00742
- Event key
- 0
- Event type
- 3
- Date received
- 2015-07-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. DANIA PEREZ
- Address
- 4555 RIVERSIDE DRIVE PALM BEACH GARDENS FL 33410 US
- Phone
- 561-561-5617
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-17 | 0 |
Event Narratives#
D
Patient 1
THE DOCTOR INDICATES THE INNER STERILE SEAL OF THE CONTAINER HOLDING BONE PRODUCT WAS BROKEN. ALL OUTER PACKAGING WAS SEALED PROPERLY WITH NO NOTICEABLE DAMAGE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT CONTAINER OF BONE.
N
Patient 1
UPON VISUAL INSPECTION, THE RETURNED JAR WAS BROKEN INSIDE THE PRODUCT PACKAGING. THE OUTER PACKAGING IS IN EXCELLENT CONDITION WITH NO OBSERVABLE DAMAGE FROM A DROP OR PRODUCT HANDLING. THERE IS OBSERVABLE BREAKAGE ON THE THREADED PORTION OF THE PRODUCT CONTAINER. THE PRODUCT WAS SENT TO MANUFACTURER UMTB BIOMEDICAL FOR INVESTIGATION. THE UMTB QUALITY DEPARTMENT REVIEWED THE PRODUCT AND THE DAMAGE ON THE LIP OF THE JAR WAS CONFIRMED. THE RETURNED OUTER BOXES USED TO PACKAGE THE DENTAL PRODUCT JARS WERE VISUALLY INSPECTED. IT WAS NOTED THAT THE BOXES WERE INTACT AND FREE OF ANY SIGNS OF PHYSICAL DAMAGE, VERIFYING THAT THE BOXES INTEGRITY HAD NOT BEEN COMPROMISED. UMTB PERFORMED A RANDOM INSPECTION OF DENTAL JARS AND FOUND NO DAMAGE. DROP TESTS OF THE PRODUCT WERE PERFORMED AND NO EVIDENCE OF PHYSICAL DAMAGE OBSERVED. THE LOT IN-PROCESS INSPECTION WAS REVIEWED AND UMTB PRODUCT MET ALL MATERIAL AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPPING. THE DENTAL PRODUCT JARS ARE 100% INSPECTED AND PASSED ALL THE INSPECTION STEPS REQUIRED BY THE PROCEDURE(S). THE DEVICE HISTORY RECORD WAS REVIEWED AND NO NONCONFORMITY WAS FOUND. THE ROOT CAUSE OF THE DAMAGE COULD NOT BE DETERMINED.
N
Patient 1
ALTHOUGH THE FINAL EVALUATION HAS BEEN RECEIVED THE PRODUCT WILL CONTINUE TO BE MONITORED.