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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG SURGICAL MESH Back to Search Results
Catalog Number 0112780
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Sweating (2444)
Event Date 08/13/2020
Event Type  Injury  
Manufacturer Narrative

As reported, the patient experienced hypotension, dizziness and sweating after the implant procedure of perfix plug, which resolved following administration of atropine. Multiple attempts have been made to obtain additional information. However, based on the information provided to date, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patient¿s reported symptoms. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in october, 2019. Should additional information be provided, a supplemental mdr will be submitted. Remains implanted.

 
Event Description

As reported, the patient underwent a hernia repair surgery for the implant of a perfix plug on (b)(6) 2020. After the surgery, the patient developed transient hypotension and complained of sweating and dizziness. The bp was 75/45mmhg; rapid rehydration was provided with 0. 5mg atropine following which bp was 115/75mmhg. The patient's condition improved and healed.

 
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Brand NamePERFIX PLUG
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
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
andrew topoulos
100 crossings blvd.
warwick, RI 02886
8005566756
MDR Report Key10647800
MDR Text Key210362241
Report Number1213643-2020-20015
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK922916
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 09/22/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0112780
Device LOT NumberHUDV2513
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/19/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/08/2020 Patient Sequence Number: 1
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