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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD CHROMIC GUT; SUTURE, ABSORBABLE, NATURAL
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DAVIS & GECK CARIBE LTD CHROMIC GUT; SUTURE, ABSORBABLE, NATURAL Back to Search Results
Model Number GG-122
Medical Device Problem Code Unraveled Material (1664)
Health Effect - Clinical Code Wound Dehiscence (1154)
Date of Event 12/20/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, postoperative from a scrotal procedure, the midline scrotal incision looks good though the upper 1 -1.5 cm wound had opened up.It was stated that it looked like the sutures have already absorbed in this region.There was no drainage, erythemia or significant swelling noted.A topical skin adhesive was applied over this upper part of the incision with good results.The patient tolerated this without issue.There was no patient injury.
 
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Brand Name
CHROMIC GUT
Common Device Name
SUTURE, ABSORBABLE, NATURAL
Manufacturer (Section D)
DAVIS & GECK CARIBE LTD
zona franca de san isidro
santo domingo 0101
DO  0101
MDR Report Key8398548
Report Number9612501-2019-00449
Device Sequence Number252997
Product Code GAL
UDI-Device Identifier10884521054899
UDI-Public10884521054899
Combination Product (Y/N)N
Initial Reporter StateAR
Initial Reporter CountryUS
PMA/510(K) Number
K885018
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberGG-122
Device Catalogue NumberGG-122
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/12/2019
Initial Report FDA Received Date03/07/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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