FDA Adverse Event
Malfunction
Summary report: N
PDS LL PLUS ANTIBACTERIAL SUTURE
MDR report key: 2992167
·
Received March 7, 2013
Report
- Report Number
- 2210968-2013-02067
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- February 10, 2013
- Report Date
- February 14, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- NEW
- PMA / PMN Number
- K061037
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DR
- 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): 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) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE BUT PRIOR TO USE ON THE PATIENT THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 97203 | PDS LL PLUS ANTIBACTERIAL SUTURE | SUTURES, ABSORBABLE | NEW | ETHICON, INC. | NA | EG5092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |