MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	L-1796K
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Tissue Damage (2104); No Code Available (3191)
Date of Event	04/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter: the patient underwent an open tube shunt eye procedure.The suture was used for tying the shunt.The surgeon used the standard technique of three throws.One week post operation, the suture thread broke.The suture became unraveled and dehisced.The patient had to come back for a reoperation.A competitors suture had to be used to close the defect.There was temporary injury as a result of the event because the wound dehisced.This also resulted in non-permanent tissue damage.The patient status is alive, no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary post market vigilance (pmv) led an evaluation of three device.The visual inspection and functional evaluation of the sample had acceptable results.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.If information is provided in the future, a supplemental report will be issued.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• MDR Report Key: 6591844
• Report Number: 9612501-2017-05544
• Device Sequence Number: 11001427
• Product Code: GAM
• UDI-Device Identifier: 20884521046358
• UDI-Public: 20884521046358
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/04/2018

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 Expiration Date: 10/31/2021
• Device Model Number: L-1796K
• Device Catalogue Number: L-1796K
• Device Lot Number: D6K2452X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2017
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 05/01/2017; 12/07/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 09/07/2017; 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 79 YR