FDA Adverse Event
Injury
Summary report: N
INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER
MDR report key: 3810126
·
Received May 14, 2014
Report
- Report Number
- 2210968-2014-06025
- Event Type
- Injury
- Date Received
- May 14, 2014
- Date of Event
- April 25, 2014
- Report Date
- April 28, 2014
- Manufacturer
- ETHICON INC.
- Product Code
- MCN
- PMA / PMN Number
- P880047
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON AN UNKNOWN DATE AND AN ABSORBABLE ADHESION BARRIER WAS USED. THERE MIGHT BE THE POSSIBILITY FOR THE PATIENT TO BE INFECTED. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288644 | INTERCEED* (TC7) ABSORBABLE ADHESION BARRIER | BARRIER, ABSORBABLE, ADHESION | MCN | ETHICON INC. | UNK | GLB7822 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |