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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 Migration (4003)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/10/2022
Event Type  malfunction  
Event Description
Fda medwatch / fda user facility report (b)(4) reported that the foreign body was removed from the patient¿s abdominal wound during the wound clinic visit. There was no reported injury. Additional information received 03may2022 reported that as of 17feb2022, the site was overall healed with no residual pain.
 
Manufacturer Narrative
The actual complaint product was not returned for evaluation. Root cause could not be determined. A review of the device history record is not possible as no lot number was provided. All information reasonably known as of 07 may 2022 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. 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).
 
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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 Key14338046
MDR Text Key295500071
Report Number9611594-2022-00059
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 Other,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number98701
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/15/2022
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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