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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 Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/18/2018
Event Type  malfunction  
Manufacturer Narrative
Aspen surgical received a report from the distributor indicating that a bioclusive pouch had product with seal issues.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.Device not returned.
 
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 Name
BIOCLUSIVE 10X12CM STERILE
Type of Device
FILM 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 Key8252633
MDR Text Key133332849
Report Number1836161-2019-00006
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 Other
Type of Report Initial
Report Date 12/21/2018
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 Other
Device Model NumberBIP1012
Device Lot Number165731
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/21/2018
Initial Date FDA Received01/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2018
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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