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

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.

• Brand Name: PERFIX PLUG
• Type of Device: SURGICAL 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 Key: 10647800
• MDR Text Key: 210362241
• Report Number: 1213643-2020-20015
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• 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 Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0112780
• Device Lot Number: HUDV2513
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2019
• 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