MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD POLYSORB; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	UL-102
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994); Swelling (2091); No Code Available (3191)
Date of Event	10/03/2019
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-operative a successful laparoscopic appendectomy, the patient called in due to redness, swelling, pain and called incision drainage.It was noted that the cable head did not absorb.An immediate use of disposable incision kit disinfection treatment, cleaned up the thrum of the absorption and gave iodine volts disinfection, anti-inflammatory oral amoxicillin dispersible tablets and adverse reactions improved.

• Brand Name: POLYSORB
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 18750 ; DO 18750
• MDR Report Key: 9435138
• Report Number: 9612501-2019-02347
• Device Sequence Number: 4202123
• Product Code: GAM
• UDI-Device Identifier: 20884521049410
• UDI-Public: 20884521049410
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2019

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 Expiration Date: 09/30/2023
• Device Model Number: UL-102
• Device Catalogue Number: UL-102
• Device Lot Number: D8J2654X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/08/2019
• 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: Required Intervention
• Patient Age: 24 YR