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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; LAP SPONGE IN TOTAL KNEE PACK
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MEDLINE INDUSTRIES INC.; LAP SPONGE IN TOTAL KNEE PACK Back to Search Results
Catalog Number DYNJ901964
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/12/2016
Event Type  Injury  
Manufacturer Narrative
It was reported prior to surgical knee procedure a lap sponge count was performed, after surgery the count was off by one.An x-ray and an rf scan were performed to locate the lap sponge.Staff also looked through the trash and linens per facility procedure, lap sponge was not found.No medical intervention was reported.No medical intervention was reported and patient was subsequently discharged home two days later.No adverse patient consequence has been reported.In an abundance of caution the medwatch is being filed.Device not returned.
 
Event Description
The facility reported a sponge miscount post procedure.
 
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Type of Device
LAP SPONGE IN TOTAL KNEE PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
one medline place
mundelein IL 60060
Manufacturer Contact
megan debus
one medline place
mundelein 60060
8476433962
MDR Report Key6088891
MDR Text Key59466742
Report Number1423395-2016-00050
Device Sequence Number1
Product Code LRO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/09/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2016
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Catalogue NumberDYNJ901964
Device Lot Number16GB4188
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Hospital
Date Manufacturer Received10/13/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
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