FDA Adverse Event
Malfunction
Summary report: N
PDS LL PLUS ANTIBACTERIAL SUTURE
MDR report key: 2840425
·
Received November 20, 2012
Report
- Report Number
- 2210968-2012-07507
- Event Type
- Malfunction
- Date Received
- November 20, 2012
- Date of Event
- October 25, 2012
- Report Date
- November 1, 2012
- Manufacturer
- ETHICON, INC. - JUAREZ
- Product Code
- NEW
- PMA / PMN Number
- K061037
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-07506. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PDS LL PLUS ANTIBACTERIAL SUTURE | SUTURES, ABSORBABLE | NEW | ETHICON, INC. - JUAREZ | NA | CBZ545 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |