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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. LAP SPONGE FROM TOTAL JOINT PACK

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MEDLINE INDUSTRIES, INC. LAP SPONGE FROM TOTAL JOINT PACK Back to Search Results
Catalog Number DYNJ57161
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/01/2018
Event Type  Malfunction  
Manufacturer Narrative

It was reported that "fuzz" was found on the lap sponge and the "fuzz" ended up inside of the patient. Despite good faith efforts to obtain additional information, the reporting facility was unable or unwilling to provide any further patient, product, or procedural details. No information was provided on exactly where within the lap sponge the "fuzz" was found and what medical intervention was required to retrieve the "fuzz" from the patient. Due to the reported incident and in an abundance of caution, this medwatch is being filed. The lap sponge was not returned for evaluation. A sample of a piece of cotton-like material approximately ½-inch long was returned in a specimen cup for evaluation. A root cause could not be determined at this time. No additional information is available. If additional information becomes available, a supplemental medwatch will be filed.

 
Event Description

It was reported that "fuzz" was found on the lap sponge and the "fuzz" ended up inside of the patient.

 
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Type of DeviceLAP SPONGE FROM TOTAL JOINT PACK
Manufacturer (Section D)
MEDLINE INDUSTRIES, INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
bermon punzalan
three lakes drive
northfield, IL 60093
MDR Report Key7931089
MDR Text Key122634937
Report Number1423395-2018-00053
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYNJ57161
Device LOT Number18FBI435
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/12/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 10/03/2018 Patient Sequence Number: 1
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