FDA Adverse Event
Malfunction
Summary report: N
SURGICAL STAINLESS STEEL SUTURE
MDR report key: 3784672
·
Received May 1, 2014
Report
- Report Number
- 2210968-2014-05536
- Event Type
- Malfunction
- Date Received
- May 1, 2014
- Date of Event
- March 28, 2014
- Report Date
- April 11, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- GAQ
- PMA / PMN Number
- K946173
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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 4 MONTH OLD INFANT UNDERWENT SURGERY FOR A CONGENITAL HEART DEFECT ON (B)(6) 2014 AND SUTURE WAS USED TO CLOSE THE STERNUM. ON (B)(6) 2014, DURING A ROUTINE X-RAY IT WAS NOTED THAT ONE OF THE SUTURES WAS BROKEN. THERE HAS BEEN NO MEDICAL OR SURGICAL INTERVENTION. THE PATIENT IS UNDER OBSERVATION. THERE HAS BEEN NO REPORTED ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 261599 | SURGICAL STAINLESS STEEL SUTURE | SUTURE, NONABSORBABLE, STEEL | GAQ | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |