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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BIOCLUSIVE 10X12CM STERILE FILM DRESSING

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ASPEN SURGICAL PRODUCTS, CALEDONIA BIOCLUSIVE 10X12CM STERILE FILM DRESSING Back to Search Results
Model Number BIP1012
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that a bioclusive pouch had product in the seal. No injury/death was reported. A manufacturing lot number was available for evaluation. No sample or photographic evidence were provided for review. The dhr and analysis results were reviewed. All samples passed acceptance criteria. No non-conformance's were noted related to the reported issue. With no sample or photo available, issue could not be confirmed. No further information is available on the product at this time. However, if a sample becomes available and any additional relevant information is identified following evaluation, any additional relevant information will be submitted in a supplemental report.
 
Event Description
Aspen surgical received a report from the distributor indicating that a bioclusive pouch was discovered with seal issues. The item was not in use. No injury/death was reported. This report was filed in our complaint handling system as number (b)(4).
 
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Brand NameBIOCLUSIVE 10X12CM STERILE
Type of DeviceFILM DRESSING
Manufacturer (Section D)
ASPEN SURGICAL PRODUCTS, CALEDONIA
6945 southbelt dr. s.e.
caledonia MI 49316
Manufacturer (Section G)
SAME AS ABOVE
Manufacturer Contact
jordan hackert
6945 southbelt dr. s.e.
caledonia, MI 49316
6165367508
MDR Report Key8170941
MDR Text Key131792895
Report Number1836161-2018-00131
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation
Type of Report Initial
Report Date 11/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberBIP1012
Device Lot Number166631
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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