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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SHEATH SHORT 5.5MM BURR EP-1; SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SHEATH SHORT 5.5MM BURR EP-1; SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 7205470
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)
Event Date 01/01/1901
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that after surgery with dyonics short sheath (handle), one patient was bleeding and had an infection of the prosthesis.This incident was noticed in a retrospective post-market clinical follow up activity (pmcf) where anonymized data summarizing outcomes were gathered; therefore, additional information is not known and it is not possible to collect it.
 
Manufacturer Narrative
The reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.Insufficient product identification information was provided, and thus, a manufacturing record review could not be conducted.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The information provided does not provide insight or relevance to current clinical outcomes for the device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.Therefore, no further interpretation of the attached images is required.No further medical assessment is warranted at this time.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
 
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Brand Name
SHEATH SHORT 5.5MM BURR EP-1
Type of Device
SAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
MDR Report Key12451140
MDR Text Key270774209
Report Number1219602-2021-01918
Device Sequence Number1
Product Code HAB
UDI-Device Identifier23596010252290
UDI-Public23596010252290
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7205470
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/16/2021
Initial Date FDA Received09/09/2021
Supplement Dates Manufacturer Received10/12/2021
Supplement Dates FDA Received11/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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