MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2015-09-02 for DUODERM? HYDROACTIVE? GEL, STERILE- 30 GRAMS 187987 manufactured by Convatec Limited.
[24796270]
On (b)(6) 2015, a batch history and detailed batch record review was performed; all required specifications were met and documented within the batch records. There were no discrepancies noted in the batch record related to the reported complaint issue. No previous investigations are available. There is not enough information to conclude the product did not meet specification and perform as intended. No corrective action investigation has been completed for this issue. This is the second complaint for this batch and issue. No further complaints for this issue and icc. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required, and the complaint will be closed. Based on the available information, this event is deemed to be a reportable malfunction. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[24796271]
End user reported a slit like area to the bottom left of the tube. End user informed she had used the tube a total of ten times before the tube split. Additional information was obtained from the end user on (b)(6) 2015, where the end user stated that she had three tubes of the duoderm gel in her possession at the time of the reported issue and that she switched to another tube when she discovered the slit in the tube that she had been using. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[28650689]
Additional information was received on (b)(6) 2015. No sample or photograph received to review. It was discovered on 09/10/2015 that the manufacturing date on initial mdr 1000317571-2015-00077 that was submitted on september 01, 2015 was incorrect. Has been updated to reflect the correct information. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2015-00077 |
| MDR Report Key | 5048987 |
| Report Source | CONSUMER |
| Date Received | 2015-09-02 |
| Date of Report | 2015-06-29 |
| Date of Event | 2015-06-28 |
| Date Mfgr Received | 2015-09-07 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2015-09-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MATTHEW WALENCIAK |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Manufacturer G1 | CONVATEC |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUODERM? HYDROACTIVE? GEL, STERILE- 30 GRAMS |
| Generic Name | DRESSING, WOUND, HYDROGEL W/OUT DRUG AND/OR BIOLOGIC |
| Product Code | NAE |
| Date Received | 2015-09-02 |
| Model Number | 187987 |
| Device Expiration Date | 2018-02-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH52NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-02 |