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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: O&M HALYARD, INC. SEQUENTIAL H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM) STERILIZATION PRODUCTS

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O&M HALYARD, INC. SEQUENTIAL H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM) STERILIZATION PRODUCTS Back to Search Results
Model Number 68248
Device Problem Material Puncture/Hole (1504)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2018
Event Type  malfunction  
Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 10-oct-2018 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by o&m halyard, inc. , represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to o&m halyard, inc. O&m halyard, inc. , has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. (b)(4).
 
Event Description
It was reported that there were two holes on the middle and the edge of the wrap. After surgery, the customer noticed this issue. The customer stated that they are not sure if the holes were opened before use or after use. Additional information was received 18-sept-2018 that states, an email was received, hole was noticed post sterilization. Additional information was received 19-sept-2018 that states, the customer found holes after surgery. However, they were not sure if the hole opened up before sterilization. There was no patient injury. Additional information was received 25-sept-2018 that states there were no problem with the patient.
 
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Brand NameSEQUENTIAL H400 STERILIZATION WRAP, 48IN. X 48IN. (121CM X 121CM)
Type of DeviceSTERILIZATION PRODUCTS
Manufacturer (Section D)
O&M HALYARD, INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
HALYARD NORTH CAROLINA, LLC
389 clyde fitzgerald road
linwood NC 27299
Manufacturer Contact
carolyn waits
5405 windward parkway
3rd floor west
alpharetta, GA 30004
4704485135
MDR Report Key7950970
MDR Text Key123841018
Report Number1054380-2018-00004
Device Sequence Number1
Product Code FRG
UDI-Device Identifier20680651682486
UDI-Public20680651682486
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K082554
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number68248
Device Catalogue Number991068248
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/25/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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