MAUDE Adverse Event Report: 3M HEALTH CARE TEGADERM NON-ADHERENT CONTACT LAYER; 878.4020 DRESSING, WOUND, OCCLUSIVE

Catalog Number 5644

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 12/29/2014

Event Type  Injury  

Event Description

Customer reported patient had abdominal wound exploration for abscess associated from acute diverticula perforation associated from acute diverticula perforations of the sigmoid colon on (b)(6) 2014.Reported abdomen was intentionally left open following surgery.Reported approximately 3-4 large (8x10) tegaderm contact layer dressings were applied to open abdominal wound followed by a wound vacuum device.Stated he did not think there were any other products applied in between the tegaderm contact layer and the wound vacuum device.Reported tegaderm contact layer adhered to bowel and in the process of removing it during dressing change on (b)(6) 2014, the patient experienced a partial thickness bowel tear which required suturing for repair.Customer reported the surgeon stated the bowel was very friable and the suture puncture sites leaked requiring additional suture repair and application of fibrin agent.Customer reported the patient is still in the hospital, but no longer in icu.Reported surgeon stated patient is not expected to have additional "sequelae" related to this event.

Manufacturer Narrative

Specific lot number: unk.Potential lot numbers reported as: sterile separates 2017-02da 2016-10ca, 2015-05da.3m catalog #5466 provided as part of medela invia wound therapy tier 1 large wound dressing set, medela item #0877071, lot# unk.(b)(6).(b)(4).Method: device not received.Results: no evaluation performed.Conclusions: device not returned no evaluation can be performed.Device not provided to manufacturer.Complaint type is being monitored and analyzed.Reporter did not have information about removal of product.See scanned page.

• Brand Name: TEGADERM NON-ADHERENT CONTACT LAYER
• Type of Device: 878.4020 DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): 3M HEALTH CARE; st. paul MN 55144 100
• Manufacturer (Section G): 3M EDUMEX S.A. DE C.V.; 6620 oriente; calle ramon rivera lara; cd. juarez, chihuahua 3269 0; MX 32690
• Manufacturer Contact: karen rittle, regulatory manage ; 275-5w-06; saint paul, MN 55144-1000 ; 6517330074
• MDR Report Key: 4416924
• MDR Text Key: 5168740
• Report Number: 2110898-2015-00002
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5644
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDELA INVIA WOUND THERAPY; MEDELA ITEM #0877071, LOT # UNK; TIER 1 LARGE WOUND DRESSING SET
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 35 YR