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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH Back to Search Results
Catalog Number 5959812
Device Problem Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Malfunction  
Manufacturer Narrative

As reported the sepramesh ip was hydrated per the instructions-for-use (ifu). The ifu recommends that sepramesh ip be completely immersed for a few seconds (1-3 seconds) in standard irrigation solution immediately prior to placement in order to maximize the flexibility of the prosthesis. The prosthesis must be rolled after hydration along its long axis (lengthwise) with the bioresorbable coating inside to protect the bioresorbable coating. Handling section recommends use clean, sterile gloves and/or atraumatic instruments, in order to preserve the integrity of the bioresorbable coating. It is not advisable to overstretch the prosthesis during handling. At this time, no conclusion can be made as to the cause of the reported problem. The device was implanted. No lot number was provided; therefore, a review of the manufacturing records is not possible. Should additional information be provided a supplemental emdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned.

 
Event Description

Due to a shortage of ventralight st the facility was made aware that sepramesh ip could be used as an alternative device. A doctor as site refused to use sepramesh ip as a substitute for ventralight st when given the option. The doctor alleged that the product has flaking issue with the coating. Bd/davol requested additional information from the facility related to the allegation of a problem with the product. Hospital contact reported that the product has not been used at the facility in more than two years. Facility contact spoke with or manager who alleged that the event took place more than two years ago. Contact reported the sepramesh ip was hydrated per requirement, quick dip. It was then noted the coating flaked. The sepramesh ip was used to treat the patient. There is no adverse patient outcome reported to have presented due to use of the device. At this time the facility was able to provide no case specific details such as date of event, or product lot number.

 
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Brand NameSEPRAMESH IP
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
francesca santamaria
100 crossings blvd.
warwick, RI 02886
4018258538
MDR Report Key7654843
MDR Text Key113172487
Report Number1213643-2018-02291
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK063739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 07/02/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/02/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number5959812
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 Received06/08/2018
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 Initial

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