MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON BIOSYN* 1 27 UNDYED GS-21; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	CM845
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter; following a successful completion of a cesarean section, the patient experience a wound dehiscence, which was later attributed to being a result of the suture by the doctor.Additional information has been requested but not yet received.
Additional Manufacturer Narrative
(b)(4).Post market vigilance (pmv) led an evaluation of three biosyn* 1 27 undyed gs-21sealed the visual inspection and functional evaluation of the product had acceptable results.Visual and functional testing of the returned product confirmed the product met quality release specifications that were tested regarding the reported condition and the reported condition was not confirmed.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• MDR Report Key: 5976721
• Report Number: 1219930-2016-01011
• Device Sequence Number: 16297861
• Product Code: GAM
• UDI-Device Identifier: 20884521032085
• UDI-Public: (01)20884521032085(17)180131(10)B3A0250X
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K000037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2016

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?: No
• Operator of Device: Health Professional
• Device Model Number: CM845
• Device Catalogue Number: CM845
• Device Lot Number: B3A0250X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/26/2016
• Supplement Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1