FDA Adverse Event
Malfunction
Summary report: N
PDS LL PLUS ANTIBACTERIAL SUTURE
MDR report key: 2992223
·
Received March 7, 2013
Report
- Report Number
- 2210968-2013-02076
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- February 8, 2013
- Report Date
- February 13, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- NEW
- PMA / PMN Number
- K061037
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR AN ABDOMINAL AORTIC ANEURYSM ON (B)(6) 2013 AND SUTURE WAS USED. WHILE GRASPING THE NEEDLE WITH FORCEPS TO REMOVE FROM PACKAGE, THE NEEDLE PULLED OFF THE SUTURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97409 | PDS LL PLUS ANTIBACTERIAL SUTURE | SUTURES, ABSORBABLE | NEW | ETHICON, INC. | NA | EJZ746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |