FDA Adverse Event
Malfunction
Summary report: N
PDS LL PLUS ANTIBACTERIAL SUTURE
MDR report key: 2821842
·
Received November 6, 2012
Report
- Report Number
- 2210968-2012-07079
- Event Type
- Malfunction
- Date Received
- November 6, 2012
- Date of Event
- October 11, 2012
- Report Date
- October 12, 2012
- 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: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Additional Manufacturer Narrative · 1
(B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE EVALUATION FOUND A SHORT INSERTION.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A GASTRECTOMY PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. THE NEEDLE WAS EASILY DETACHED FROM THE SUTURE DURING KNOTTED SUTURING OF THE FASCIA. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PDS LL PLUS ANTIBACTERIAL SUTURE | SUTURE, ABSORBABLE | NEW | ETHICON, INC. | NA | EGK647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |