MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON POLYSORB* 5/0 18 UNDYED P-11

Model Number SL5626

Device Problems Break (1069); Component Falling (1105)

Patient Problem Wound Dehiscence (1154)

Event Type  Injury  

Event Description

(b)(4) are separate cases which were batch reported.According to the reporter: sutures are breaking at knots (interrupted skin sutures) and the patients are having dehiscence multiple patients.Was the device used in patient: yes was there patient injury/hazard: yes if yes, describe injury/treatment: dehiscence there was no unanticipated tissue loss, no unanticipated ext.Of incision more than 1 inch, no unanticipated blood loss of more than 500cc.Was the delay over 30 minutes: yes if yes, did delay affect the patient? the patients all had dehiscence and were required to come back to the office for more stitches to close their wound.Reason product not returned: they fell out of the patients in their normal lives - the patients did not have sutures to bring back to the office.Note: ftr comment:sutures are breaking at knots (interrupted skin sutures) and the patients are having dehiscence.Multiple patients.Additional product is sp5681g, lot #d4e1258x.In all 6 codes of sutures are having issues.

Manufacturer Narrative

(b)(4).

• Type of Device: POLYSORB* 5/0
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06743 ; 2034925267
• MDR Report Key: 4411769
• MDR Text Key: 5282952
• Report Number: 1219930-2015-00033
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL5626
• Device Catalogue Number: SL5626
• Device Lot Number: B4E1442X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other