MAUDE Adverse Event Report: ETHICON INC. PRINEO SKIN CLOSURE SYSTEM SURGICAL SEALANT

Catalog Number CLR602

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hypersensitivity/Allergic reaction (1907); Irritation (1941); Itching Sensation (1943); 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 a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent a mammoplasty procedure on (b)(6) 2016 and topical skin adhesive was used. Three days after the procedure, the patient presented an allergic reaction with severe itching in the surgical wound. It was also reported that the tape of topical skin adhesive was removed. The doctor prescribed an antiallergic drug and ointment. Since then, the patient experienced more irritation at the site, where topical skin adhesive tape was removed, and the mastologist prescribed another healing ointment. Additional information has been requested.

Manufacturer Narrative

The actual device batch number associated with this event is not known. The international affiliate reports the following possible batch numbers: batch# hgp399 exp date: 05/11/2016, mfr date: 06/19/2014. Batch# hgb631, exp. Date: 05/2016. In addition, a review of the batch manufacturing records for the possible batch number hgp399 was only conducted at this time and the batch met all finished goods release criteria. Visual inspection shows that the tray packages are closed and sealed. No damages or anomalies are observed on the tyvek or blister material. The printed graphics and information is clear and legible. Also the applicators and mesh dispensers are contained inside the tray package and no anomalies or defects are observed. Since this complaint is related to formulation performance, samples were forwarded for chemical testing and the cause cannot be determined from the analyses performed. The patient sensitivity cannot be measured. It is possible that the customer is sensitive to the initiator bac. Although the samples received were beyond their expiry date. All criteria, that was measured, was met the specification requirements for the device. The devices functioned as designed.

• Brand Name: PRINEO SKIN CLOSURE SYSTEM
• Type of Device: SURGICAL SEALANT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; 982 road 183 km 8.3; san lorenzo PR 00754
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 5783730
• MDR Text Key: 49231065
• Report Number: 2210968-2016-10302
• Device Sequence Number: 1
• Product Code: OMD
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K082289
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: CLR602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 07/11/2016 Patient Sequence Number: 1