MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC

Model Number	L-2750K
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	06/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post operatively, on an open strabismus ophthalmology surgery, on the connection of the lower 2 conjunctiva muscle attachments, the surgeon stated that 3 suture muscle attachments were placed in strabismus surgery; one top and two on the bottom of the eye conjunctiva, but it was observed that the two lower sutures had unraveled.The patient was hospitalized and returned to surgery to re-attach the unraveled 2 suture muscle attachments.The surgical time was extended by 30 minutes or more due to the product problem.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 195 mcdermott rd; north haven CT 06473
• MDR Report Key: 12294419
• Report Number: 1219930-2021-03241
• Device Sequence Number: 17324597
• Product Code: GAM
• UDI-Device Identifier: 10884521046504
• UDI-Public: 10884521046504
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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 Model Number: L-2750K
• Device Catalogue Number: L-2750K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2021
• Initial Report FDA Received Date: 08/09/2021
• 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; Required Intervention
• Patient Age: 3 YR