MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-11-18 for OLEEVA FABRIC SOLD AS SCARAWAY SIL SHEET 1.5X7 IN 12'S manufactured by Bio Med Sciences, Inc..
[60416000]
On (b)(6) 2016 consumer presented to an urgent care and placed on oral bactrim for 5 days for diagnosis of infection of incision. At this urgent care visit on (b)(6) 2016 the hcp attempted to drain the incision, however it would not drain. On (b)(6) 2016 consumer was seen at her obgyn office for follow up and a culture swab of incision site was performed and sent to a lab for testing. Results of this culture came back on (b)(6) 2016 as a skin staph infection. On (b)(6) 2016 consumer was first seen at her obgyn office in regards to findings of results and from there admitted to the "6th floor" medical surgical unit at the hospital on (b)(6) 2016 for iv antibiotic therapy. She was on three different iv antibiotics at first, however none were working. On (b)(6) 2016 she was switched to a 4th iv antibiotic. Consumer could not recall names of these iv antibiotics. During the hospital stay she had blood work to check her white blood count on (b)(6) 2016, however consumer is unsure of these results. On (b)(6) 2016 a cat scan was performed in attempt to find the source of liquid coming from the pimples at incision site, however results of cat scan were normal, and no source was found such as any pus pockets. During the hospital stay an attempt to drain the incision was again made, however it still would not drain. Consumer was discharged from the hospital on (b)(6) 2016 with oral antibiotic cephalexin intended to be used for only 10 days; however consumer ended up needing to use this medication for a total of 20 days. She stopped use of the cephalexin on (b)(6) 2016. Her last scheduled follow up appointment with her hcp was on (b)(6) 2016 and she has no further planned follow up appointments at this time. The consumer reported the pimples at the application site are healing as in they are scabbing, however are still there. She also reported as long as the scabs stay in place there is no further liquid coming from the pimples at the application site, however when she showers and the scabbing softens or a scab falls off the liquid does still come out. The consumer did not wish to provide permission for (b)(6) to contact her hcp. Consumer did not advise of any other signs or symptoms of infection that presented. Consumer herself did not do anything to treat events. She stated overall she is healthy and has no concomitant medications. No recent changes to her diet or medications were made at the time of product use. Our investigation process has included a cross-functional team comprised of technical experts with 74 years of clinical scar/wound management experience, a medical doctor, a licensed pharmacist, and supporting qa/regulatory professionals. The investigation included an evaluation for how a product designed and labeled for use as a closed wound application could result in an infection condition. The product, including biocompatibility data, historical product performance data, a labeling review and general medical knowledge for types of infections that can occur post-op was evaluated. We have made numerous attempts to request the medical records to better understand the details of the post-op conditions and general skin condition of the customer at the initiation of product use. Unfortunately, at this time we have limited information to support a further in depth review of factors/modes for how the product did or did not contribute to this event. Based on our product data and knowledge to date, we believe the use of scaraway? On intact skin is not likely to contribute to an infection and that the patient either used it on an open wound or the infection was preexisting. We will continue to track and trend our quality data. Thus as we cannot rule out product contribution, we are reporting this event due to the consumer information available which included hospitalization and treatment for an infection. We wish to be fully diligent in our reporting responsibilities.
Patient Sequence No: 1, Text Type: N, H10
[60416001]
Consumer had a c-section performed on (b)(6) 2016 and was cleared by her doctor to use scaraway after incision was determined by her hcp to be healed. On (b)(6) 2016 consumer used scaraway for the first time and applied one sheet, once, topically to her c-section incision and upon removing it on (b)(6) 2016 noticed she had pimples at the application site, and liquid coming from the pimples.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2529394-2016-00001 |
| MDR Report Key | 6115027 |
| Report Source | CONSUMER |
| Date Received | 2016-11-18 |
| Date of Report | 2016-11-15 |
| Date of Event | 2016-10-24 |
| Date Mfgr Received | 2016-10-24 |
| Device Manufacturer Date | 2014-10-02 |
| Date Added to Maude | 2016-11-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. DENA HANKEE |
| Manufacturer Street | 7584 MORRIS COURT SUITE 218 |
| Manufacturer City | ALLENTOWN PA 181069250 |
| Manufacturer Country | US |
| Manufacturer Postal | 181069250 |
| Manufacturer Phone | 6105303193 |
| Manufacturer G1 | PERRIGO COMPANY |
| Manufacturer Street | 1692 12TH STREET |
| Manufacturer City | ALLEGAN MI 490708745 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 490708745 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLEEVA FABRIC SOLD AS SCARAWAY SIL SHEET 1.5X7 IN 12'S |
| Generic Name | ELASTOMER, SILICONE, FOR SCAR MANAGEMENT |
| Product Code | MDA |
| Date Received | 2016-11-18 |
| Returned To Mfg | 2016-11-16 |
| Lot Number | C0236 |
| Device Expiration Date | 2019-10-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO MED SCIENCES, INC. |
| Manufacturer Address | 7584 MORRIS COURT SUITE 218 ALLENTOWN PA 181069250 US 181069250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention | 2016-11-18 |