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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RAYNHAM SURG PATXRAY 1/4X1/4-200; SURGICAL PATTIES

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RAYNHAM SURG PATXRAY 1/4X1/4-200; SURGICAL PATTIES Back to Search Results
Catalog Number 801399
Device Problem Material Frayed (1262)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2019
Event Type  malfunction  
Manufacturer Narrative
Attempts are being made to obtain additional information.Upon completion of the investigation, a follow-up report will be submitted.
 
Event Description
It was reported that the surg patxray threads were sticking to the patient's tissue on (b)(6) 2019.The staff have reported that while patties were being used to clean away lasered tissue in the patients larynx, threads were coming loose from the patties and sticking to the patients good tissue.Threads had to be picked off so not to potentially cause residual infection for the patient post operatively, due to foreign body present; it needed to be removed manually.Another packet was accessed for use and the same occurred.
 
Event Description
N/a.
 
Manufacturer Narrative
Complaint sample was not returned for evaluation therefore; an evaluation of the device could not be performed.Lot number information has been provided; therefore, manufacturing records were reviewed and found no anomalies.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Between 05nov2019 and 30jun2020, approximately 2,200 mdrs submitted electronically by integra lifesciences via trackwise, integra's complaint handling system, were not received by cdrh due to a computer system issue.Within this time period, an error with integra's middleware, which facilitates communications between trackwise and the fda system, caused the complaint records to close and indicate we had received an acknowledgement 3 from the fda when we had not.Integra interpreted the acknowledgement as a successful submission; however, subsequent investigation revealed the acknowledgement 3 received was from our middleware and not from the fda (these acknowledgements have been retained as part of the documentation of the mdr).The malfunction was related to the relocation of the trackwise application to a new data center during the transition of integra's corporate headquarters from plainsboro, nj to princeton, nj.Previously, integra had been successfully receiving acknowledgements 1, 2, and 3 from the fda, and our records reflect these acknowledgements, including the date and time stamps.Capa pr 229048 and nc 20-011 have been opened by integra to further investigate the nonconformance and develop a corrective action plan.The middleware error has been corrected, and integra has filed mdrs since the correction and verified that the appropriate acknowledgements have been received from the fda.Integra is resubmitting all impacted mdr reports for the time period 05nov2019 through 30jun2020.Integra lifesciences contacted (b)(4), director of regulatory programs, office of product evaluation and quality and (b)(4), assistant director, mdr team, office of product evaluation and quality on july 8-9, 2020 to report these issues regarding mdr reports.
 
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Brand Name
SURG PATXRAY 1/4X1/4-200
Type of Device
SURGICAL PATTIES
Manufacturer (Section D)
RAYNHAM
325 paramount drive
325 paramount drive
raynham MA 02767
MDR Report Key8929988
MDR Text Key155654823
Report Number1226348-2019-00366
Device Sequence Number1
Product Code HBA
Combination Product (y/n)N
PMA/PMN Number
K880402
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2022
Device Catalogue Number801399
Device Lot NumberHN0979
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/09/2019
Initial Date FDA Received08/26/2019
Supplement Dates Manufacturer Received03/11/2020
Supplement Dates FDA Received07/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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