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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
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COVIDIEN LP LLC NORTH HAVEN POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID Back to Search Results
Model Number SL-694
Medical Device Problem Codes Break (1069); Unraveled Material (1664)
Health Effect - Clinical Codes Wound Dehiscence (1154); Inflammation (1932)
Type of Reportable Event Malfunction
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 a veterinary procedure, the device thread broke that caused the wound to re-open and inflame.To resolve the issue, the veterinarian had to re-operate the patient and used a new suture.
 
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Brand Name
POLYSORB
Common Device Name
SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key11292269
Report Number1219930-2021-00512
Device Sequence Number3479191
Product Code GAM
UDI-Device Identifier10884521049253
UDI-Public10884521049253
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K963253
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/08/2021
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 Date01/31/2025
Device Model NumberSL-694
Device Catalogue NumberSL-694
Device Lot NumberA0B0417FY
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/15/2021
Initial Report FDA Received Date02/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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