FDA Adverse Event
Malfunction
Summary report: N
AQUACEL AG SURGICAL DRS4X20CM1X10STER DE
MDR report key: 3964426
·
Received June 19, 2014
Report
- Report Number
- 1000317571-2014-00037
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 23, 2014
- Report Date
- May 26, 2014
- Manufacturer
- CONVATEC LIMITED
- Product Code
- FRO
- PMA / PMN Number
- K013814
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED THAT THE PACKAGE IS NOT SEALED AND THE ISSUE WAS FOUND BEFORE USE. AN EMAIL WAS SENT TO REQUEST ADDITIONAL INFORMATION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED "PRODUCT PACKAGING NO PRESSURE, RESULTING CONTAMINATED EXPOSED DRESSINGS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 359453 | AQUACEL AG SURGICAL DRS4X20CM1X10STER DE | DRESSING, WOUND, DRUG | FRO | CONVATEC LIMITED | 403740 | 3F01474 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |