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

Model Number	CL-835-L
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/03/2017
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the needle-thread combination was torn and was discerpted in two cases.No further details provided.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of a device.The sample opened by the client was received degraded.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage could not be reliably determined.Replication of the observed damage may occur if it is exposed to prolonged high temperatures or the temperature of the environment when it is out of its packaging.The exposure time for the product is up to 672 hours.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.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 (26) twenty six devices.The sample opened by the client was received degraded.A review of the device history record (dhr) indicates the product was released meeting all quality release specifications at the time of manufacture.The root cause of the observed damage could not be reliably determined.Replication of the observed damage may occur if it is exposed to prolonged high temperatures or the temperature of the environment when it is out of its packaging.The exposure time for product is up to 672 hours.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: 6915327
• Report Number: 9612501-2017-06341
• Device Sequence Number: 1444286
• Product Code: GAM
• UDI-Device Identifier: 10884521042124
• UDI-Public: 10884521042124
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/20/2018

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 Expiration Date: 06/30/2019
• Device Model Number: CL-835-L
• Device Catalogue Number: CL-835-L
• Device Lot Number: D4F1169X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2017
• Initial Date Received by Manufacturer: 09/07/2017
• Supplement Date Received by Manufacturer: 01/02/2018; 05/31/2018
• Initial Report FDA Received Date: 10/05/2017
• Supplement Report FDA Received Date: 01/24/2018; 06/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1