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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL INC. GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS DH EF PERC PLACEMENT PRODUCTS

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AVANOS MEDICAL INC. GASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS DH EF PERC PLACEMENT PRODUCTS Back to Search Results
Model Number 98701
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Skin Inflammation (2443); Post Operative Wound Infection (2446)
Event Date 06/22/2020
Event Type  Injury  
Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 21 jul 2020 has been included in this health authority report. Avanos medical inc. Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the avanos medical complaint database and identified as complaint (b)(4).
 
Event Description
It was reported by the patient's parent that the patient had a reaction to the sutures at the stoma site. The sutures were placed to secure a gastric feeding tube on (b)(6) 2020, and on (b)(6) 2020, pinkness and irritation was noted at the site. On (b)(6) 2020, a doctor prescribed keflex, and on (b)(6) 2020 the patient was taken to the emergency department for removal of the sutures. The patient was also given a prescription for mupirocin, as the site was red and oozing and was deemed to be infected. By (b)(6) 2020 the patient was clear of the infection and had no adverse effects. Additional information has been requested but not yet received.
 
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Brand NameGASTROINTESTINAL ANCHOR SET, SAF-T-PEXY T-FASTENERS
Type of DeviceDH EF PERC PLACEMENT PRODUCTS
Manufacturer (Section D)
AVANOS MEDICAL INC.
5405 windward parkway
alpharetta GA 30004
Manufacturer (Section G)
AVENT SA DE R.L. DE C.V. (AVENT 1)
circuito industial no.40
colonia obrera
nogales, cp 84048
MX 84048
Manufacturer Contact
lisa clark
5405 windward parkway
alpharetta, GA 30004
4704485444
MDR Report Key10329527
MDR Text Key200606861
Report Number9611594-2020-00132
Device Sequence Number1
Product Code KGC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K080253
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Model Number98701
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/07/2020
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

Patient Treatment Data
Date Received: 07/27/2020 Patient Sequence Number: 1
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