MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 OPTIFIX STRAIGHT; STAPLE, IMPLANTABLE

Catalog Number	0113126
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Fatigue (1849); Pain (1994); Depression (2361)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, the patient had constant pain, loss of mobility in right leg, loss of appetite, loss of hair and weight post implant of non-bd mesh which was fixated using the optifix straight device.Based on the event as reported the degree to which the optifix fixation device used to treat the patient may have caused or contributed to the patient¿s post-operative course cannot be determined.Note that the optifix fastener is a resorbable fastener that completes reabsorption within 360 days and would no longer be present in the patient's body three years after implant.The adverse reaction section of the instructions-for-use, supplied with the device identifies pain as a possible complication.Review of manufacturing records confirms product was manufactured to specification.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Per ansm user report ((b)(4): it was reported that, "since the insertion of hernia repair mesh for an umbilical hernia, my life has been hell, with my health deteriorating, as confirmed by a medical examination! my life is in danger and i am in intense pain, requiring morphine.Since the operation, i have requested that the mesh be removed urgently, even if i have to go to germany to have it done since the implant was fitted, i have been in agony since waking up after the operation.The pain has been downplayed by the nursing staff, who tell me i am exaggerating and that it is all in my head.The operation should have been an outpatient procedure, but i have been hospitalized ever since and my life is no longer the same.Comments: it is criminal to implant this type of prosthesis.I am a carer and i was not suspicious enough.I thought i could trust the surgeon, but they stole my life.My five children have lost their mother, who often has to lie down because of the intolerable pain.I am unable to send you the necessary documents.Error detected.Patient information: current patient status: since this material was implanted, i have been surviving.My general condition is deteriorating rapidly.I have lost 25 kg and am in constant pain (eva 8 on the right side at the level of the abdominal, pelvic and inguinal prosthesis), plus i am losing mobility in my right leg.I am experiencing severe hair loss and have lost my appetite.I am unable to eat and feel overwhelming fatigue.I have already contemplated suicide because the pain is so unbearable.I am currently seeing professor r in hautepierre to request removal of the device.Actions taken by the healthcare facility to treat the patient: nr.The patient was implanted with non-bd mesh (material péters surgical, cousin biotech, promesh surg intra) for umbilical hernia repair.The mesh was fixated using optifix fixation device.This report represents the bd optifix fixation device.

• Brand Name: OPTIFIX STRAIGHT
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 24202203
• Report Number: 1213643-2026-00046
• Device Sequence Number: 21248243
• Product Code: GDW
• UDI-Device Identifier: 00801741074318
• UDI-Public: (01)00801741074318(17)230928(10)HUFX1837
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2026

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: 0113126
• Device Lot Number: HUFX1837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability; Other
• Patient Sex: Female