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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 7.5 PWDR LATEX ST SURG GLOVE 4X50; SURGICAL GLOVES
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COVIDIEN 7.5 PWDR LATEX ST SURG GLOVE 4X50; SURGICAL GLOVES Back to Search Results
Model Number TPPHS75A
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Submit date: 05/10/2016.An investigation is currently underway.Upon completion, the results will be forwarded.
 
Event Description
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a surgical glove.The customer reports that the gloves are broken at the fingertips.
 
Manufacturer Narrative
On 5/10/2016 an emdr was generated and sent to the fda; however upon further clarification, this item or a similar device is not sold in the us and therefore a mdr should not have been generated.
 
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Brand Name
7.5 PWDR LATEX ST SURG GLOVE 4X50
Type of Device
SURGICAL GLOVES
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer (Section G)
COVIDIEN
15 hampshire street
mansfield MA 02048
Manufacturer Contact
thom mcnamara
15 hampshire street
mansfield, MA 02048
5084524811
MDR Report Key5644439
MDR Text Key45815965
Report Number1282497-2016-00196
Device Sequence Number1
Product Code KGO
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberTPPHS75A
Device Catalogue NumberTPPHS75A
Device Lot Number2023475
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received05/13/2016
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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