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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, INC. SCALPEL HOLDER RED; ASPEN LEAF WITH BARD-PARKER; STERILE
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ASPEN SURGICAL PRODUCTS, INC. SCALPEL HOLDER RED; ASPEN LEAF WITH BARD-PARKER; STERILE Back to Search Results
Model Number ST-100
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical recieved a report from the distributor indicating that product was found with seal issues.The actual device will be returned for evaluation.The manufacturing lot numbers were provided for review.If any additional relevant information is identified, the additional relevant information will be submitted in a supplemental report.
 
Event Description
Aspen surgical received a report from outside distributor indicating that product st-100 was discovered with sealing issues.No injury/death was reported.This is entered in our system as (b)(4).
 
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Brand Name
SCALPEL HOLDER RED; ASPEN LEAF WITH BARD-PARKER; STERILE
Type of Device
SCALPEL HOLDER
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, INC.
6945 southbelt dr.se
caledonia MI 49316
Manufacturer Contact
karen clausen
6945 southbelt dr. se
caledonia, MI 49316
6166987100
MDR Report Key18969654
MDR Text Key338688842
Report Number3002750084-2024-00010
Device Sequence Number1
Product Code FSM
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/25/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberST-100
Device Lot Number359853
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/01/2024
Was Device Evaluated by Manufacturer? No
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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