FDA.reportPublic FDA data

MAUDE MDR 9580431

MDR report key
9580431
Report number
2210968-2020-00300
Event key
0
Event type
3
Date of event
2019-12-13
Date received
2020-01-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GUT CHR UD 27IN 2-0 S/A SHSUTURE, ABSORBABLE, NATURALETHICON INC.GALG123HR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-1301. R

Event Narratives#

N

Patient 1

(B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

D

Patient 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A TONSILLECTOMY PROCEDURE AND SUTURE WAS USED. THE SUTURE WAS USED ON THE SOFT PALATE AND THE NEEDLE BROKE OFF AND FELL INTO THE PATIENT. THE PIECES OF THE NEEDLE WERE FOUND AND RETRIEVED BY CUTTING AWAY ADDITIONAL TISSUE AND RETRIEVED WITH A NEEDLE HOLDER. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THE CURRENT CONDITION OF THE PATIENT IS REPORTED AS GOOD CONDITION.