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

Model Number	SM-5624
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of product.The visual inspection of the samples had acceptable results.Functional testing could not be performed because the returned samples had passed their expiration date.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.
Event or Problem Description
According to the reporter, several customers showed allergic reaction.

• Brand Name: BIOSYN
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): COVIDIEN LP LLC NORTH HAVEN; 60 middletown ave; north haven CT 06473
• MDR Report Key: 7495837
• Report Number: 1219930-2018-02501
• Device Sequence Number: 19186656
• Product Code: GAM
• UDI-Device Identifier: 10884521033047
• UDI-Public: 10884521033047
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K000037
• 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
• Report Date (Section B): 05/08/2018

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 Model Number: SM-5624
• Device Catalogue Number: SM-5624
• Device Lot Number: B1H0707X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 05/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1