FDA.reportPublic FDA data

MAUDE MDR 2833127

MDR report key
2833127
Report number
9612030-2012-00055
Event key
0
Event type
3
Date of event
2012-07-12
Date received
2012-11-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARLA CALDERON
Address
15 HAMPSHIRE ST MANSFIELD MA 02048 US
Phone
508-508-5082
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ENEMA BAGENEMA BAGCOVIDIENFCE145540145540UNK* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-11-0701. O

Event Narratives#

D

Patient 1

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH AN ENEMA BAG. THE CUSTOMER REPORTS; THE PT REPORTED RECTAL FULLNESS AND BLOOD ON TOILET PAPER. AN ANEMA HAD BEEN ADMINISTERED EARLIER IN THE DAY. UPON EXAMINATION A BLUE, APPROX 5-INCH PLASTIC CAP FROM THE ENEMA BAG TUBING, WAS FOUND IN THE PT'S RECTUM. THE RN DID NOT REALIZE THE CAP SHOULD BE REMOVED. THERE IS NO LABELING ON THE CAP NOT TO INSERT INTO PT. THERE IS ALSO NOTHING IN THE PRODUCT LITERATURE TO ENSURE THE CAP IS REMOVED AND DISPOSED OF PRIOR TO INSERTION INTO PT.

N

Patient 1

SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED. COVIDIEN PRODUCT MONITORING CONTACTED THE CUSTOMER ON (B)(4) 2012 TO REQUEST ADD'L INFO. ON (B)(4) 2012, (B)(4) FROM THE RISK MANAGEMENT OFFICE COMMUNICATED THAT PER HOSPITAL'S POLICY, INFO REGARDING PT'S MEDICAL PROCEDURES IS CONSIDERED CONFIDENTIAL AND NO ADD'L INFO COULD BE PROVIDED. (B)(4) FURTHER STATED THAT PT'S CONDITION IS STABLE.