IDRT-TS (INTL) SINGLE 4X5 84051

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-30 for IDRT-TS (INTL) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corporation.

Event Text Entries

[71334765] Integra has completed their internal investigation on march 27, 2017. The investigation included: methods: review of device history records. Review of complaints history. Results: the failure is unconfirmed. No failure analysis could be performed as the product was used on the patient during surgery, and has not returned. Dhr review; the nc/event log and batch record were reviewed for any events related to the lots of the components used to manufacture the product. Any events or ncs related to the parent dispersion lot or the reported finished goods lot of any time period was considered. No events or ncs were found for this lot or it? S component lots related to skin visual appearance defects. Complaints history; a query of the complaint database for the timeframe of 12 months ((b)(6) 2016-(b)(6) 2017) was performed using the individual keywords:? Skin? And? Thick? Or? Thin? Or? Uneven?. No other complaints were found. Conclusion: the root cause is likely user misinterpretation of the required thickness range for idrt. Based on the complaint background provided, review of the batch production records and trending, risk analysis, and the complaint type, it can be determined that the doctor noticed a visual difference in the thickness of both idrt sheets when compared, but based on the manufacturing process of the complaint lot, no failure occurred. Company sop defines uneven or descending thickness of sponge from end to end > 2:1 ratio as a defect. Manufacturing performs 100% visual inspection of all sponges per sop to ensure each device meets this criterion. If an out of specification thickness was identified with any device during inspection, the impacted device would be rejected. Thickness does inherently vary for the coated skin products, but the thickness of both the uncoated product and silicone is checked/documented in process and was within the acceptable range. Products are only released based on finished goods release testing and batch record criteria.
Patient Sequence No: 1, Text Type: N, H10


[71334766] 2 of 2 reports - other mfg report number: 1121308-2017-00004. It was reported a thickness issue on two idrt layers: one is thicker than and the other is thinner than usual. The customer was not able to confirm which device of the two was thicker or thinner, but when the customer compared the two devices they were both visually different in thickness. No patient injury reported and the event did not lead to surgical delay.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1121308-2017-00005
MDR Report Key6445677
Report SourceCOMPANY REPRESENTATIVE
Date Received2017-03-30
Date of Report2017-02-10
Date Mfgr Received2017-06-29
Device Manufacturer Date2016-06-01
Date Added to Maude2017-03-30
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 ContactUSER SONIA IRIZARRY
Manufacturer Street311 ENTERPRISE DRIVE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal08536
Manufacturer Phone6099362393
Manufacturer G1INTEGRA LIFESCIENCES CORPORATION
Manufacturer Street105 MORGAN LANE
Manufacturer CityPLAINSBORO NJ 08536
Manufacturer CountryUS
Manufacturer Postal Code08536
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameIDRT-TS (INTL) SINGLE 4X5
Generic NameIDRT-TS
Product CodeMDD
Date Received2017-03-30
Returned To Mfg2017-04-17
Catalog Number84051
Lot Number105NKA352492
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerINTEGRA LIFESCIENCES CORPORATION
Manufacturer Address105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536


Patients

Patient NumberTreatmentOutcomeDate
10 2017-03-30

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