LAP CHOLE PACK 89-6201

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-08-31 for LAP CHOLE PACK 89-6201 manufactured by Deroyal Industries, Inc..

Event Text Entries

[84104160] Investigation summary an internal complaint (call (b)(4)) was received indicating that a lap chole pack (finished good 89-6201, lot 42061936) contained a fenestrated key drape that was flaking, allowing debris into the surgical site. The sample is reported to be available for return. However, as of the date of this report, the sample had not been received for evaluation. The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. The affected drape (raw material (b)(4)) was supplied to deroyal by (b)(4). A supplier corrective action request (b)(4) was issued august 15, 2017, and a response is due september 26, 2017. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10


[84104161] The fenestrated key sheet was flaking, which led to debris in the surgical site.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005011024-2017-00013
MDR Report Key6833560
Report SourceDISTRIBUTOR
Date Received2017-08-31
Date of Report2018-02-21
Date of Event2017-08-10
Date Mfgr Received2017-08-10
Date Added to Maude2017-08-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSARAH BENNETT
Manufacturer Street200 DEBUSK LANE
Manufacturer CityPOWELL TN 37849
Manufacturer CountryUS
Manufacturer Postal37849
Manufacturer Phone8653626112
Manufacturer G1DEROYAL INDUSTRIES, INC.
Manufacturer Street1501 EAST CENTRAL AVENUE
Manufacturer CityLAFOLLETTE TN 37766
Manufacturer CountryUS
Manufacturer Postal Code37766
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLAP CHOLE PACK
Generic NameLAPAROSCOPY KIT
Product CodeFDE
Date Received2017-08-31
Returned To Mfg2017-09-15
Model Number89-6201
Lot Number42061936
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEROYAL INDUSTRIES, INC.
Manufacturer Address1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-31

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