FDA Adverse Event
Malfunction
Summary report: N
PDS LL PLUS ANTIBACTERIAL SUTURE
MDR report key: 3003819
·
Received March 14, 2013
Report
- Report Number
- 2210968-2013-02442
- Event Type
- Malfunction
- Date Received
- March 14, 2013
- Report Date
- February 18, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- NEW
- PMA / PMN Number
- K061037
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED AND THEY MET THE REQUIREMENTS.
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION ON AN UNKNOWN DATE AND SUTURE WAS USED. DURING THE PROCEDURE THE NEEDLE BROKE. ALL OF THE NEEDLE FRAGMENTS WERE RETRIEVED FROM THE PATIENT . THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 107344 | PDS LL PLUS ANTIBACTERIAL SUTURE | SUTURE, ABSORBABLE | NEW | ETHICON, INC. | NA | EH5135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |