FDA Adverse Event
Malfunction
Summary report: N
PDS II (POLYDIOXANONE) SUTURE
MDR report key: 4221397
·
Received November 3, 2014
Report
- Report Number
- 2210968-2014-15247
- Event Type
- Malfunction
- Date Received
- November 3, 2014
- Date of Event
- October 14, 2014
- Report Date
- October 15, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- NEW
- PMA / PMN Number
- N18331
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. PRIOR TO USE ON THE PATIENT IT WAS NOTED THAT THE NEEDLE WAS STICKING OUT OF THE PACKAGE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701191 | PDS II (POLYDIOXANONE) SUTURE | SUTURE, SURGICAL, ABSORBABLE | NEW | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |