FDA Adverse Event
Injury
Summary report: N
SURGICAL STAINLESS STEEL SUTURE
MDR report key: 3022529
·
Received March 27, 2013
Report
- Report Number
- 2210968-2013-03007
- Event Type
- Injury
- Date Received
- March 27, 2013
- Date of Event
- February 25, 2013
- Report Date
- February 26, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- GAO
- PMA / PMN Number
- K946173
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- 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 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 CABG PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE STERNAL CLOSURE, THE NEEDLE TIP BROKE AND BECAME EMBEDDED IN THE STERNUM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125739 | SURGICAL STAINLESS STEEL SUTURE | SUTURE, NON-ABSORBABLE | GAO | ETHICON, INC. | NA | EKE484 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |