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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE; SURGICAL BLADE
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ASPEN SURGICAL PRODUCTS, CALEDONIA BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE; SURGICAL BLADE Back to Search Results
Model Number 371110-150
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/08/2023
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received a medwatch form (mw5118385) stating that a blade broke while being used.The broken half was retrieved.The actual device was not returned for evaluation.The manufacturing lot number was not provided for review.Photographic evidence was not provided for review.There was no injury/death to the patient.After investigation, the root cause was undetermined.
 
Event Description
Aspen surgical received a medwatch form (mw5118385) stating that a blade broke while being used.The broken half was retrieved.There was no injury/death to the patient.This event was filed in our complaint handling system as (b)(4).
 
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Brand Name
BARD-PARKER CARBON RIB-BACK BLADES SIZE 10, STERILE
Type of Device
SURGICAL BLADE
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
terry hall
6945 southbelt dr. s.e.
caledonia, MI 49316
6166987100
MDR Report Key17347293
MDR Text Key319618286
Report Number1836161-2023-00022
Device Sequence Number1
Product Code GES
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 Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number371110-150
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/22/2023
Initial Date FDA Received07/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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