MAUDE Adverse Event Report: ETHICON INC. INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER; BARRIER, ABSORBABLE, ADHESION

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Unspecified Infection (1930); Inflammation (1932); Seroma (2069); Discharge (2225); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.

Event Description

It was reported in a journal article that the patient underwent a partial mastectomy with insertion of adhesion barrier -purposed oxidized regenerated cellulose filling material for partial defects of the breast on unknown date and the absorbable adhesion barrier was used.During radiotherapy, the patient developed severe infection at the operative site and the turbid seroma was continuous aspiration from the cavity.The aspiration of abscess and antibiotics treatment was maintained during the radiotherapy.After consecutive radiotherapy, the erythematous lesion occurred on operative scar and stale discharge was drained from the wound.In the wound culture, (b)(6).The infection was completely cured in the acute stage.The shrinkage of the operative site after the inflammation led to asymmetry of the breasts, which was judged as a poor cosmetic outcome.Additional information has been requested.

• Type of Device: BARRIER, ABSORBABLE, ADHESION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): UNKNOWN; unknown; x
• Manufacturer Contact: darlene kyle ; route 22 west po box 151; somerville, NJ 08876 ; 9082182792
• MDR Report Key: 6586228
• MDR Text Key: 75815171
• Report Number: 2210968-2017-32241
• Device Sequence Number: 1
• Product Code: MCN
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P880047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/24/2017
• 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: 53 YR