FDA Adverse Event
Injury
Summary report: N
ETHIBOND EXTRA & EXCEL POLYESTER SUTURE
MDR report key: 3083073
·
Received April 29, 2013
Report
- Report Number
- 2210968-2013-04660
- Event Type
- Injury
- Date Received
- April 29, 2013
- Report Date
- April 8, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- GAS
- PMA / PMN Number
- N17804
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-04661. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PEDIATRIC PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. APPROXIMATELY 4 TO 6 WEEKS POST-OPERATIVELY, THE PATIENT EXPERIENCED SPITTING OF THE SUTURE AT THE UMBILICUS . THE PATIENT UNDERWENT A SECOND SURGERY TO REMOVE THE SUTURES. DURING THE PROCEDURE, GRANULOMA FORMATION AND TISSUE BREAKDOWN WERE FOUND. ADDITIONAL INFORMATION REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 185130 | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE | SUTURE, NON-ABSORBABLE | GAS | ETHICON, INC. | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |