FDA Adverse Event
Injury
Summary report: N
4 4-18 " STEEL MONO V-40
MDR report key: 3215961
·
Received July 10, 2013
Report
- Report Number
- 2210968-2013-12723
- Event Type
- Injury
- Date Received
- July 10, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 27, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- GAQ
- PMA / PMN Number
- K946173
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
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 AN INFANT UNDERWENT A PROCEDURE TO REPAIR BROKEN SUTURE IN THE CHEST ON (B)(6) 2013. ON (B)(6) 2013, AN X-RAY SHOWED THE SUTURE WAS BROKEN. THE PATIENT UNDERWENT A RE-OPERATION ON (B)(6) 2013. CURRENTLY, THE PATIENT IS STILL IN THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 318448 | 4 4-18 " STEEL MONO V-40 | SUTURE, NON-ABSORBABLE | GAQ | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |