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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD SURGIPRO; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
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DAVIS & GECK CARIBE LTD SURGIPRO; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE Back to Search Results
Model Number CP-412
Medical Device Problem Code Unraveled Material (1664)
Health Effect - Clinical Codes Abdominal Distention (2601); No Code Available (3191)
Date of Event 10/15/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, four days following an epigastric hernia repair, the patient returned to the emergency room with a distended abdomen and there was an evidence of total dehiscence of sutures and complete evisceration.An intervention was performed to place a mesh.
 
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Brand Name
SURGIPRO
Common Device Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key9256707
Report Number9612501-2019-02097
Device Sequence Number14103198
Product Code GAW
UDI-Device Identifier10884521036123
UDI-Public10884521036123
Combination Product (Y/N)N
Initial Reporter CountryCO
PMA/510(K) Number
K954808
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberCP-412
Device Catalogue NumberCP-412
Device Lot NumberD9B219Y
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/15/2019
Initial Report FDA Received Date10/30/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age40 YR
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