MAUDE Adverse Event Report: CP MEDICAL VISORB; POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE

Model Number	497A-CP1
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples were available from the customer so retained samples (n=5) were tested.One sample was visually and manually tested.The needle was firmly attached.The other samples were subjected to needle pull test as per usp specifications.The test results yielded a force of 6.390 lbf.The specification for this size and material is that the needle pull strength be a minimum of 1.51 lbf.Therefore the samples were within specification.
Event or Problem Description
The customer reported a needle detachment on size 3/0 pga suture which happened during a dermatological procedure (cystic lesion on scalp).

• Brand Name: VISORB
• Common Device Name: POLYGLYCOLIC ACID (PGA), ABSORBABLE SURGICAL SUTURE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; ste 150; norcross GA 30093 2960
• MDR Report Key: 11038488
• Report Number: 3012164473-2020-00002
• Device Sequence Number: 2651714
• Product Code: GAM
• UDI-Device Identifier: 10790986000688
• UDI-Public: 10790986000688
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K002190
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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 Date: 05/31/2024
• Device Model Number: 497A-CP1
• Device Catalogue Number: 497A-CP1
• Device Lot Number: 190628-52
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR