MAUDE Adverse Event Report: ETHICON INC. SURGICAL GUT SUTURE -PLAIN; SUTURE, ABSORBABLE, NATURAL

Catalog Number U203T

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem Surgical procedure (2357)

Event Date 04/23/2015

Event Type  Injury  

Event Description

It was reported that the patient underwent circumcision on an unknown date and suture was used.Following the procedure, the patient experienced pre-absorption of the suture.The patient underwent another surgical procedure.Additional information has been requested.

Manufacturer Narrative

(b)(4).Conclusion: representative samples were returned for evaluation.Visual inspection was performed for appearance, color, packages, wrinkles in the seal area, continuous seals, seal margins, over-sealing, damage and holes.No defects were noted.Functional inspection was performed for knot and swage tensile and the samples met the requirements.Additional information: the actual device batch number associated with this event is not known.The international affiliate reports the following possible batch numbers: batch 985373, mfg date: 04/2014, exp date: 04/2019; batch 987142, mfg date: 04/2014, exp date: 04/2019.In addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.

Manufacturer Narrative

The physician opined that the patient¿s mother did not listen to the doctor¿s aftercare request and that the mother also could have tampered with the wound.

• Brand Name: SURGICAL GUT SUTURE -PLAIN
• Type of Device: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-BRAZIL; rodovia presidente dutra, km 1; 54; sao paolo 1224 0-90; BR 12240-908
• Manufacturer Contact: mary szaro ; route 22 west po box 151; somerville, NJ 08876 ; 9082183464
• MDR Report Key: 4884790
• MDR Text Key: 17201657
• Report Number: 2210968-2015-07745
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: U203T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR