FDA Adverse Event
Injury
Summary report: N
PROLENE POLYPROPYLENE MESH
MDR report key: 2972901
·
Received February 21, 2013
Report
- Report Number
- 2210968-2013-01589
- Event Type
- Injury
- Date Received
- February 21, 2013
- Report Date
- July 12, 2018
- Manufacturer
- ETHICON, INC.
- Product Code
- OTO
- PMA / PMN Number
- K013718
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
(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.
Additional Manufacturer Narrative · 1
(B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCE URGE INCONTINENCE AND ATROPHIC VAGINITIS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2009 AND A MESH WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 77191 | PROLENE POLYPROPYLENE MESH | MESH, SURGICAL | OTO | ETHICON, INC. | NA | ALP842 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |