MAUDE Adverse Event Report: DGH TECHNOLOGY, INC. PACHMATE HANDHELD PACHYMETER; PACHYMETER, 90 IYO

Model Number DGH 55

Device Problem Use of Device Problem (1670)

Patient Problem Corneal Abrasion (1789)

Event Date 01/01/2015

Event Type  No Answer Provided  

Event Description

An international distributor submitted a rma request through the company website on (b)(6) 2015.While inspecting the device for repair (b)(6) 2015 the rma was reviewed and it was found that an injury was described: " i have a pachmate with a fault that i cannot seem to remedy.The customer said too much force/pressure is needed to be able to get a measurement.I could get it to take measurements on my hand intermittently, although i don't think doing this is the best simulation.After further issues with the instrument i sent the customer a replacement probe (both probes with instrument).Not only did the issue persist, but the doctor also scratched the patient's cornea due to the force needed to take a measurement.I would like if dgh could take a look at this instrument for me.Would it be possible to get an rma number and consider a replacement probe if necessary?" currently patient information, operator information date and extent of injury is unknown.It is also unknown if any medical treatment or intervention was required due to the injury.

Manufacturer Narrative

Visual inspection - inspection of the 2 probes (sn (b)(4)) returned with the dgh 55 device (sn (b)(4)) did not reveal any deformation or damage that would have resulted in the patient's cornea being scratched.Visual inspection of device showed no obvious signs of neglect/abuse.Probe verification - probe sn (b)(4) is the original probe provided with the device and was found to be within specifications for a new probe.Probe sn (b)(4) is the replacement probe provided by the distributor.The measured probe output was below the initial setup target for new probes, however output was within the operational range of the device.Unit verification - the unit was checked for measurement accuracy using dgh pachymeter measurement standard device (dpmsd) box #1.All readings were within tolerance.On eye measurements were taken using the device and both probes.There was no indication of any difficulty in obtaining measurements with the device.Conclusion - device misuse.Under no circumstances should the user apply excessive pressure when applanating the probe to the cornea.

Manufacturer Narrative

Follow up - on 07/14/2015, (b)(6) (dgh) spoke with a representative from the hospital where the event took place.He was informed that antibiotics were prescribed as a preventative measure.The patient recovered with no complications or permanent impairment/damage.Dgh 55 unit 2010-6925 was found to be in good working order, however a replacement device will be sent to the customer.Dgh 55 unit 2010-6925 will be maintained at dgh.

Event Description

At the time this report was first submitted, it was unknown the extent of the injury.On 07/14/2015, (b)(6) (dgh) was able to contact the hospital where the event took place.He was informed that antibiotics were prescribed to the patient as a preventative measure.The patient recovered with no complications or permanent impairment/damage.

• Brand Name: PACHMATE HANDHELD PACHYMETER
• Type of Device: PACHYMETER, 90 IYO
• Manufacturer (Section D): DGH TECHNOLOGY, INC.; 110 summit dr., suite b; exton PA 19341
• Manufacturer Contact: david henderson ; 110 summit dr., suite b; exton, PA 19341 ; 6105949100
• MDR Report Key: 4795623
• MDR Text Key: 5883304
• Report Number: 2522950-2015-00001
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K033385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor,distributor,foreign
• Reporter Occupation: Not Applicable
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DGH 55
• Device Catalogue Number: DGH 55
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention