FDA Adverse Event
Malfunction
Summary report: N
PDS II (POLYDIOXANONE) SUTURE
MDR report key: 1890662
·
Received November 1, 2010
Report
- Report Number
- 2210968-2010-01391
- Event Type
- Malfunction
- Date Received
- November 1, 2010
- Date of Event
- September 28, 2010
- Report Date
- September 29, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- NEW
- PMA / PMN Number
- N18331
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS REC'D, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT AN UNK SURGICAL PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE AT THE SWAGE DURING CONTINUOUS SUTURING OF THE FASCIA. NO FRAGMENT REMAINED AT THE PT'S BODY. THERE WAS NO ADVERSE PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PDS II (POLYDIOXANONE) SUTURE | SUTURE, ABSORBABLE | NEW | ETHICON, INC. | NA | CDZ582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |