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U.S. Department of Health and Human Services


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Model Number 187660
Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Correction - contact office address: dr.(b)(4).(b)(4).Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
Event Description
It was reported that the package was unsealed.The product was not used on patient.Photographs depicting the issue were received from the complainant.
Manufacturer Narrative
Batch record review: lot 9e05062 was manufactured on 06/04/2019, product description duoderm cgf drs 10x10cm (1x5pk) nai , in bodolay line, with a total of (b)(4) market units.A batch record review on 10/03/2021, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bom and all the tooling information documented was also correct.The batch record review supports that there were no discrepancies related to the issue reported.Photograph, video and/or physical sample evaluation: there are photographs associated with this case and in these, the reported defect can be seen.No unused return sample was expected.Conclusion summary of the related event: based in the analysis phase conclusions, the issue of wnd-pmc 9.6 primary pack has incomplete or open seal / weld, or is torn, ripped or contains holes or exhibits external contamination, or dressing or loose material is trapped in packaging, for products manufactured at bodolay pratt c packaging line, are attributed to the following probable causes per failure mode: for region not sealed the root causes found were: machine: misalignment of the sealing station: the misalignment of the sealing station was found as the second major contributor for the open seal (compromised sterile barrier) affecting the regions not sealed on products packed on bodolay pratt c due to the following opportunities: incorrect height of the upper sealing tooling: there was an opportunity found related to the proper high of the upper tooling of the sealing station.Currently this height is not standardized as part of the machine set up and it is a source of variation.1- malfunction of cylinders: during the investigation it was confirmed that cylinders in bad condition apply a wrong pressure during the sealing of paper and film.The preventive maintenance program of the machine was revised, and it was found an opportunity related to the non-standardized useful life of cylinders.Non-standardized use of teflon on sealing plate: current sealing tooling use teflon as a conductive of heat and to avoid paper or film to burn during the sealing of the blister.An opportunity was found because the number of layers of teflon to be used on the sealing plate has not been standardized.A capa plan will be generated for mitigate the root causes identified.Should additional information become available, a follow up report will be submitted.Fda registration number: reporting site: 1049092.Manufacturing site: 9618003.
Event Description
To date no additional patient or event details have been received.
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Brand Name
Type of Device
Manufacturer (Section D)
km 18.5 parque industrial
itabo, s.a. haina
san cristobal 91000
DR  91000
MDR Report Key12525191
MDR Text Key273103113
Report Number9618003-2021-02284
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 08/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number187660
Device Lot Number9E05062
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Manufacturer Received10/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1