MAUDE Adverse Event Report: ETHICON INC. SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE; STAPLE, IMPLANTABLE

Catalog Number STRAP12

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

Patient Problems Pain (1994); Treatment with medication(s) (2571)

Event Date 03/18/2015

Event Type  Injury  

Event Description

It was reported that a patient underwent a transabdominal preperitoneal hernia repair procedure on (b)(6) 2015 and absorbable straps were used.After the procedure, the patient immediately experienced pain on the left side.Medication for pain was prescribed.As of (b)(6) 2015, the pain was gradually relieved.

Manufacturer Narrative

(b)(4).No conclusion can be drawn at this time.Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

Manufacturer Narrative

It was reported that the patient was discharged on (b)(6) 2015.On (b)(6) 2015, the patient experienced postoperative pain on the left side at the outpatient clinic.Medicine for pain was prescribed by the surgeon at the outpatient clinic.As of (b)(6) 2015, it was reported that the surgeon confirmed the pain was relieved.

• Brand Name: SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 015
• Manufacturer (Section G): ETHICON INC.-JUAREZ; avenida de las torres 7125, co; l salvacar; ciudad juarez 3260 4; MX 32604
• Manufacturer Contact: guillermo villa ; route 22 west po box 151; somerville, NJ 08876 ; 9082180707
• MDR Report Key: 4671545
• MDR Text Key: 5609030
• Report Number: 2210968-2015-04157
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093845
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: STRAP12
• Device Lot Number: JAM301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/05/2015
• 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