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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND 4.0 25X40 CM

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TEI BIOSCIENCES INC SURGIMEND 4.0 25X40 CM Back to Search Results
Catalog Number 606-400-016
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); Reaction (2414)
Event Type  malfunction  
Manufacturer Narrative
Integra has completed their internal investigation on september 12, 2017. Results: the failure is unconfirmed, as there was no product returned for this complaint. Therefore, failure analysis could not be performed. Dhr review; no anomalies were found and all manufacturing related process steps were followed and documented per listed instructions and current good manufacturing practices. All qc inspection steps related to labeling inspection were followed as per instructions, no anomalies were found. Complaints history; a query of the complaints database for the timeframe of 03aug2016 ¿ 03aug2017 was performed using the keywords: ¿surgimend,¿ ¿soap,¿ ¿soapy,¿ ¿bubble,¿ ¿rehydrating,¿ ¿rehydrate¿ and ¿rehydration. ¿ there was one additional complaint received for this issue on the same day ((b)(6) 2017) and from the sample complaint reporter. Including this complaint, there have been a total of two complaints of ¿soapy bubble whilst rehydrating¿ related to surgimend from the past year (03 august 2016 ¿ 03 august 2017). There were approximately (b)(4) surgimend units sold (in the us and outside of the us) in the past 12 months before this complaint resulting in a calculated complaint occurrence rate is 0. 01%. Conclusion: root cause is indeterminable. The device was not returned for failure analysis as it remains implanted in the patient.
 
Manufacturer Narrative
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
 
Event Description
Second of 2 reports - other mfg report number: 3004170064-2017-00009. It was reported that there are seemingly soapy bubbles formed in the saline while rehydrating. Product was in contact with the patient; however, no patient injury reported and the event did not lead to surgical delay. According to the sales rep: my suggested technique for the larger pieces has not changed when there is not a large enough receptacle to rehydrate the mesh in whilst it is still stiff. I have just never noticed this bubble situation before that i can recall. The process is as such; once the scrub nurse has the sterile inner bag on her table, i suggest they open it just a little in the centre and pour a litre of room temp saline into the bag. Rolling the top of the bag over creates a seal as best possible and the nurse then, holding the bag at each end, creates a rocking motion which in turn, gently sloshes the device in saline and starts the softening or rehydration process once the device is suitably soft i get them to pour the water from the bag into a sterile bowel and place the mesh in there in its now softened state where they can fold it to keep it all submerged as best possible. Sometimes an additional liter of saline is added.
 
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Brand NameSURGIMEND 4.0 25X40 CM
Type of DeviceSURGIMEND
Manufacturer (Section D)
TEI BIOSCIENCES INC
7 elkins street
7 elkins street
boston MA 02127
Manufacturer (Section G)
TEI BIOSCIENCES INC
7 elkins street
boston MA 02127
Manufacturer Contact
sonia irizarry
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6853696
MDR Text Key249795197
Report Number3004170064-2017-00010
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K083898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/31/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number606-400-016
Device Lot Number1702004
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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