FDA Adverse Event
Injury
Summary report: N
PROLENE POLYPROPYLENE MESH
MDR report key: 1903529
·
Received November 16, 2010
Report
- Report Number
- 2210968-2010-01530
- Event Type
- Injury
- Date Received
- November 16, 2010
- Date of Event
- October 8, 2010
- Report Date
- October 16, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- FTL
- PMA / PMN Number
- K962530
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFECTION. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS USED. THE PT EXPERIENCED AN INFECTION. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROLENE POLYPROPYLENE MESH | MESH, SURGICAL | FTL | ETHICON, INC. | NA | V0005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |