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Model Number 187955
Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Device 10 of 14. Complainant city: (b)(6). Based on the available information, this event is deemed to be a reportable malfunction. Lot 9h00191 was manufactured on 08/13/2019 in the bodolay line with a total of (b)(4) market units. Complaint investigator id 5173 performed a batch record review on 11/18/2020 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, under icc code 187955 sap material id 1704768 and manufacturing order 1486246. The batch record review supports that there were no discrepancies related to the issue reported. Photo related to the reported problem is available for evaluation. A targeted root cause investigation for this known issue/malfunction code has been conducted. The manufacturing process, quality inspections, and quality control records were reviewed. As part of the root cause investigation, dressings with the alleged foreign matter spots were sent to an external lab to have the spots isolated from the dressing for composition testing and analysis. The result of the analysis concluded that the spots were a raw material ingredient used in the formulation of the hydrocolloid. Effects of mixing the hydrocolloid at allowable temperature variations was performed at our manufacturing facility in haina, dominican republic. The results showed that within our validated processing specifications, the number and size of spots present in the hydrocolloid could vary based on the validated range of temperature and time profiles of the mixing process. The investigation found one root cause and two contributing causes for the reported malfunction and they are as follows: root cause: the validated allowable range for the temperature and time profiles of the mixing process allowed for a raw material to become charred during the process at the higher settings. Contributing cause: the frequency of the mixer cleaning was not adequate when the mixer was run at the upper end of the validated settings. Contributing cause: the material specification for a powdered raw material used in the formulation allow for black spots. The black spots within the powder cannot be isolated and removed. The material is supplied with a certificate of analysis guaranteeing the product conforms to specification and is safe for use. As a result of the investigation, the mixing temperature and time profiles were tested under engineering studies to find the optimum set point and allowable range to prevent the charring of any of the raw materials. This optimum setting has been fully validated and the change is awaiting regulatory body approval to begin production. In addition, the cleaning frequency of the mixer has been increased to every two batch runs to ensure no potential charred material may begin to build up and eventually become present in our dressings. Product monitoring reviews will monitor for product trends if this issue were to reoccur. To date no additional patient/event information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Event Description
The end user claimed that there were black spots in dressing. The product was used by end user. There was no harm reported. A photograph depicting the issue was received from the end user.
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Brand NameL3W0750
Manufacturer (Section D)
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer (Section G)
km 18.5 parque industrial
itabo, s.a. haina
san cristobal
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
MDR Report Key10903996
MDR Text Key240378668
Report Number9618003-2020-15398
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 consumer,distributor,foreign
Type of Report Initial
Report Date 11/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number187955
Device Lot Number9H00191
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/03/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown