D
Patient 1
THE SALES REP REPORTED: SURGEON SAID THE PATTIES WERE FRAYING DURING THE PROCEDURE. HE COULD SEE THEM FRAY UNDER THE MICROSCOPE.
MAUDE MDR 3594928
- MDR report key
- 3594928
- Report number
- 1226348-2014-11182
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-01-16
- Date received
- 2014-01-28
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 403
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MR. JAMES KENNEY
- Address
- 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US
- Phone
- 508-508-5088
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SURGICAL PATTIE, 1/2 X 1/2 | SURGICAL SPONGE | CODMAN & SHURTLEFF, INC. | FQA | 80-1400 | 424137, 415306, 424140 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-01-28 | 0 | 1. R |
Event Narratives#
N
Patient 1
IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.
N
Patient 1
THE PRODUCT WAS NOT RETURNED FOR AN EVALUATION. DUE TO NOT BEING ABLE TO EVALUATE THE PRODUCT UNDER QUESTION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS COMPLAINT. A REVIEW OF THE DEVISE HISTORY RECORDS FOR THE SUBJECT DEVICE DID NOT REVEALED ANY ANOMALIES. THESE LOT CODES APPEAR TO HAVE MET ALL TESTING REQUIREMENT, THERE WERE NO ANOMALIES NOTED DURING MANUFACTURING PROCESS. LOT # 415306 WAS USED TO VERIFY CAPABILITY OF A NEW BRANSON ULTRASONIC WELDER. ALL PULL TEST DATA WAS FOUND TO BE ACCEPTABLE. WHILE THERE IS VARIATION INHERENT IN OUR MANUFACTURING PROCESS OF THE COTTONOID MATERIAL, OUR OBJECTIVE IS TO PRODUCE PRODUCT WITH THE LEAST POSSIBLE AMOUNT OF LINTING. THEREFORE LOT TO LOT VARIATION IN THE COTTONOID PROCESS MAY RESULT IN LOTS THAT LINT MORE OR LESS THAN THE NORM. "FRAYING" CAN ALSO COME FROM THE QUALITY OF THE EDGE CUT FROM THE SLITTING PROCESS, BUT IT IS NOT POSSIBLE TO DETERMINE THIS IS AN ISSUE SINCE IT IS NOT POSSIBLE TO EVALUATE THE PRODUCT UNDER QUESTION. WE WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR COMPLAINTS FOR THIS PRODUCT CODE. AT THIS TIME THIS COMPLAINT IS CONSIDERED TO BE CLOSED, SHOULD THE PRODUCT BE RETURNED AT A LATER DATE THIS COMPLAINT WILL BE REOPENED AND AN INVESTIGATION WILL BE PERFORMED.