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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORP EXTENDED TIP APPLICATOR 15CM BOX OF 5 SEALANT APPLICATORS

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INTEGRA LIFESCIENCES CORP EXTENDED TIP APPLICATOR 15CM BOX OF 5 SEALANT APPLICATORS Back to Search Results
Catalog Number 205115
Device Problem Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device is not expected to be returned to the manufacturer for analysis. The device was discarded by the customer. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation. Linked to mfg report number 3003418325-2020-00008.
 
Event Description
This is 1 of 2 reports. It was initially reported to integra on 08may2020 that the 205115 extended tip applicator has clogged during application of duraseal at two different times. They cut the very end of the tip off so they could complete the application of the duraseal. Patient contact was unknown. No patient injury reported. Additional information received on 12may2020 and 21may2020 indicating that the product was used during surgery and it happened twice during two different minimally invasive spine procedures. The date of incident occurred within (b)(6) 2020. There was a delay for at least five (5) minutes as the surgeon tried to fix the problem. There was no adverse consequence to the patient.
 
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Brand NameEXTENDED TIP APPLICATOR 15CM BOX OF 5
Type of DeviceSEALANT APPLICATORS
Manufacturer (Section D)
INTEGRA LIFESCIENCES CORP
1000 campus drive
1000 campus drive
princeton NJ 08536
Manufacturer (Section G)
INTEGRA LIFESCIENCES CORP
1000 campus drive
princeton NJ 08536
Manufacturer Contact
vivian nelson
1000 campus drive
princeton, NJ 08536
6099362319
MDR Report Key10280886
MDR Text Key202568704
Report Number3003418325-2020-00007
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K091315
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number205115
Device Lot Number2109091374
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/29/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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