D
Patient 1
COUNTRY OF COMPLAINT: (B)(6). COMPLAINT STATES: AFTER FINISHING THE SURGERY, THE CUSTOMER FOUND TIP OF THE JAW IS MISSING. AND THAT FRAGMENT HAS NOT BEEN FOUND YET.
MAUDE MDR 4047730
- MDR report key
- 4047730
- Report number
- 2916714-2014-00647
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-06-30
- Date received
- 2014-08-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MICHELLE LINK
- Address
- 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
- Phone
- 314-314-3145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HALSTED-MOSQUITO FCPSDELSTR1X2125MM | HAEMOSTATIC FORCEPS | AESCULAP AG & CO. KG | HRQ | BH120R | BH120R | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-08-08 | 0 | 1. O |
Event Narratives#
N
Patient 1
U.S. REPORTING AGENT NOTIFIED ON (B)(4) 2014. MANUFACTURING SITE EVALUATION: THE INVESTIGATION DETERMINED THE ISSUE HAD BEEN CAUSED BY A MANUFACTURING ERROR, WHICH WAS NOT DETECTED IN FINAL INSPECTION. HOWEVER, ALL RESPONSIBLE PERSONS HAVE BEEN INFORMED ABOUT IT AND IT SHOULD BE AVOIDED IN THE FUTURE. ALL KNOWN COMPLAINTS WITH THIS FAILURE HAVE BEEN PRODUCED IN 2012. AS OEM DID NOT RECEIVE ANY MORE ISSUES SINCE THEN, IT IS ASSUMED THAT ONE OR FEW BATCHES IN 2012 WERE AFFECTED.